Master in Pharmacy Duration- 2 Years Full Time Course (4 Semesters)

Proposed Programme Structure Curriculum

Faculty o! Pharmaceutical Science C " S#$# "%&'()S&TY

*adh+an City

PROPOSED REGULATIONS

FACULTY of Pharmaceutical Science C. U. S A UNI!ERSITY" #AD #AN

)egulations !or Master in Pharmacy (M, Pharm) Course

%ame o! Program- $a%ter in Pharmac& '$. Pharm( C. U. Shah Uni)er%it& offer% $a%ter in Pharmac& '$. Pharm( cour%e of t*o &ear% 'four %eme%ter%( +uration in the follo*in, %-eciali.ation. /. Pharmaceutic% 0. Pharmaceutical Technolo,& 1. 2ualit& A%%urance 3. Pharmaceutical Anal&%i% 4. Pharmacolo,& ),Pharma (P.) /, Master in Pharmacy The -o%t ,ra+uate +e,ree -ro,ram in Pharmac&" lea+in, to the +e,ree of $a%ter in
Pharmac&" i% offere+ 5& C.U.Shah Uni)er%it&.

The cour%e of %tu+& for $a%ter in Pharmac& %hall e6ten+ o)er a -erio+ of t*o aca+emic &ear% 'four %eme%ter%(. The curricula an+ %&lla5i for the cour%e% %hall 5e a% -re%cri5e+ from time to time 5& C.U.Shah Uni)er%it&. ),Pharma (P.) 2, (ligi0ility Criteria !or Master in Pharmacy $dmissiona, The %tu+ent% %ee7in, a+mi%%ion in the /%t Seme%ter of $a%ter in Pharmac& De,ree Pro,ram %hall ha)e to -a%% the 8achelor in Pharmac& e6amination or an& other reco,ni.e+ e6amination% con%i+ere+ e9ui)alent 5& the C.U Shah Uni)er%it&: 0, O)er an+ a5o)e the can+i+ate %houl+ ha)e a--eare+ the Gra+uate Pharmac& A-titu+e Te%t 'GPAT( or an& e9ui)alent entrance e6amination finali.e+ 5& the e+ucation +e-artment" Go)ernment of Gu;arat" or a% -er the amen+ment of an& rule% an+ re,ulation 5& e+ucation +e-artment Go)ernment of Gu;arat an+ C.U.Shah Uni)er%it& from time to time. c, <4 = Seat% of /%t %eme%ter $a%ter in Pharmac& a+mi%%ion %hall 5e fille+ u- 5& the >oint

A+mi%%ion Committee for Profe%%ional cour%e% '>AC?PC no* AC?PC(( con%titute+ 5& the E+ucation De-artment" Go)t. of Gu;arat Gan+hina,ar" )i+e re%olution No. P!S @/A0AA1 @ B1C @ S +ate+ A4?A4?0AAB *ith the commencement -u5li%he+ 5& com-etent authorit& time 5& time. An+ 04= %eat% %hall 5e fille+ u- a% a mana,ement 9uota %eat a% -er the ,ui+eline of >AC? PC 'no* AC?PC(. ),Pharma (P.) 1, Medium o! &nstruction ),Pharma (P.) 4, (nrollment o! StudentA+mi%%ion ,rante+ 5& the authori.e+ committee to an& %tu+ent %hall 5e -ro)i%ional till the enrollment i% ma+e 5& the C.U.Shah Uni)er%it&. In ca%e of a+mi%%ion en+or%e+ on the 5a%i% of -ro)i%ional eli,i5ilit& certificate" the con+ition% of the Uni)er%it& %hall 5e com-lie+ *ithin fi6e+ time limit failin, *hich ma& lea+ to forfeitment of can+i+ature: in *hich ca%e no fee% on an& account *ill 5e refun+e+ *hat%oe)er. ),Pharma (P.) 3, Programme composition Credits (2amination- En,li%h

A %tu+ent a+mitte+ to a -ro,ramme %houl+ %tu+& the cour%e% an+ earn cre+it% %-ecifie+ in the cour%e %tructure. Plea%e refer +etaile+ %&lla5u%. ),Pharma (P.) 4, $ttendance /( All Stu+ent% mu%t atten+ e)er& lecture" %eminar an+ -ractical cla%%e% o*e)er" to

account for late ;oinin, or other %uch contin,encie%" the atten+ance re9uirement for a--earin, the e6amination% %hall 5e a minimum of <4= of the cla%%e% actuall& hel+. 0( In or+er to maintain the atten+ance recor+ of a -articular cour%e" a roll call *ill 5e ta7en 5& the teacher in e)er& %che+ule+ lecture %eminar an+ -ractical cla%%. For the -ur-o%e of atten+ance" e)er& %che+ule+ -ractical cla%% *ill count a% on atten+ance unit" irre%-ecti)e of the num5er of contact hour%. 1( The teacher in char,e *ill con%oli+ate the atten+ance recor+ for the lecture%" %eminar% an+ -ractical for each term. Atten+ance on account of -artici-ation in national le)el %eminar" %&m-o%ium" %cientific *or7%ho-" the -re%cri5e+ function% of NCC" NSS"

Inter Uni)er%it& %-ort%" e+ucational tour% @ fiel+ *or7 recor+" +ul& counter%i,ne+ 5& the Officer In char,e" i% %ent for +ue con%i+eration to the Dean of Facult& *ithin t*o *ee7% of the function @ acti)it&" etc. 3( No e6em-tion *ill 5e ,i)en to an& %tu+ent from atten+ance e6ce-t on account of %eriou% -er%onal illne%% or acci+ent or famil& calamit& that ma& ,enuinel& -re)ent a %tu+ent from atten+in, a -articular %e%%ion or a fe* %e%%ion%. re9uire+ to 5e con+one+ 5& the Princi-al or authoritie%. 4( .rant o! Terms- The can+i+ate *ill 5e ,rante+ a term -ro)i+e+ he@%he ha% %ati%factoril& com-lete+ the -re%cri5e+ cour%e of %tu+& D ha% 7e-t <4= atten+ance for theor&" %eminar an+ -ractical '*here)er a--lica5le( %e-aratel& for each %u5;ect. Similarl& the %tu+ent *ill ha)e to 7ee- <4= atten+ance for ,ue%t Lecture%" Seminar%" Grou- Di%cu%%ion" >ournal Clu5 acti)itie% etc. o*e)er" %uch une6-ecte+ a5%ence from cla%%e% an+ other acti)itie%" ma6imum one month *ill 5e

),Pharma (P.) 5, (6aluation SystemsThe -erformance of e)er& %tu+ent in each %u5;ect *ill 5e e)aluate+ a% follo*%E B( Internal e)aluation *ill 5e of 1A= mar7% for the each %u5;ect. <( E6ternal e)aluation 5& the Uni)er%it& throu,h *ritten -a-er or -ractical te%t or oral te%t or -re%entation 5& the %tu+ent or a com5ination of an& t*o or more of the%e" for <A= of the mar7% in each %u5;ect. F( Theor& an+ Practical com-onent of the %ame %u5;ect %hall 5e con%i+ere+ a% a %e-arate %u5;ect.

),Pharma (P.) 7, &nternal e6aluation (Mid semester e2amination) a, There %houl+ 5e at lea%t t*o -erio+ic internal e)aluation of theor& -a-er +urin, each %eme%ter an+ 5e%t of one %hall 5e con%i+ere+ for calculation of %e%%ional mar7% in theor& -a-er%. A total %e%%ional mar7 for each theor& -a-er i% 1A. 0. There %houl+ 5e onl& one -ractical internal e)aluation +urin, each %eme%ter an+ the

total 1A mar7% '%e%%ional( %hall 5e allotte+ a% -er follo*in, i. Actual -erformance of -ractical e6amination ??0Amar7% ii. Da& to Da& atten+ance@Pro;ect *or7@%eminar@a%%i,nment@)i)a?)oice" etc. ??/Amar7% c, The +uration of internal e)aluation %hall 5e con+ucte+ for /.4 hour% for 1A mar7% of theor& '/ hr for /4 mar7% of theor&( an+ B hour% for -ractical e6amination. d, )emedial e2amination and8or continuous e6aluation- If the can+i+ate +o not %ecure+ 3A = mar7% in internal e6amination of theor& or -ractical" he@%he mu%t a--ear in reme+ial e6amination an+ the ma6imum internal mar7% *ill 5e not more than 3A=. e@%he %hall 5e allo*e+ to a--ear onl& one reme+ial e6amination

),Pharma (P.) 9, (2ternal e6aluation ((nd semester e2amination) The e6ternal e)aluation *ill 5e hel+ 5& the Uni)er%it& for <A= of the e)aluation for the each %u5;ect" an+ *ill 5e throu,h *ritten -a-er or -ractical te%t or oral te%t or -re%entation 5& the %tu+ent or a com5ination of an& t*o or more of the%e. The +uration of uni)er%it& e6amination 5& C. U. Shah Uni)er%it& %hall 5e for 1 hour% +uration for theor& an+ -ractical *ith not le%% than B hour%.

),Pharma (P.) /:, Dissertation *or; The +i%%ertation *or7 for $a%ter in Pharmac& -ro,ram con%i%t% of Pha%e?I an+ Pha%e?II. The Di%%ertation #or7 Pha%e?I %hall %tart +urin, %eme%ter?III an+ Di%%ertation #or7 Pha%e?II" *hich i% a continuation of Pha%e?I %hall 5e com-lete+ at the en+ of %eme%ter?I!. A can+i+ate %hall %u5mit the choice of the re%earch area an+ to-ic *ith title of the +i%%ertation imme+iate after the %eme%ter?II for the a--ro)al 5& the +e-artment hea+ an+ hea+ of the in%titution%. The uni)er%it& encoura,e for carr& out hi%@her re%earch -ro;ect in re-ute+ -harmaceutical in+u%trie%" ho%-ital% an+ re%earch or,ani.ation. It i% one of the im-ortant com-onent% for In+u%tr&?In%titute Partner%hi-. In %uch ca%e%" the Pro;ect *or7 %hall 5e ;ointl& %u-er)i%e+ 5& a %u-er)i%or of the +e-artment an+ an e6-ert a% a co?%u-er)i%or from the or,ani.ation.

The Pro;ect Re-ort -re-are+ accor+in, to a--ro)e+ ,ui+eline% an+ +ul& %i,ne+ 5& the %u-er)i%or'%( an+ the In%titution, Progress of dissertation work C( Di%%ertation *or7 %hall 5e carrie+ out un+er the %u-er)i%ion of facult& mem5er in the concerne+ +e-artment an+ the *or7 -ro,re%% to 5e maintaine+ in the -re%cri5e+ *or7 +air& an+ recor+ 5oo7. The *or7 +iar& an+ recor+ 5oo7 %hall 5e )erifie+ an+ certifie+ 5& the ea+ of the De-artment an+ ea+ of the in%titution. The certification of %ati%factor& -ro,re%% i% 5a%e+ on the *or7 +iar& an+ recor+ 5oo7. Evaluation of dissertation work /A( Each an+ e)er& can+i+ate ha% to %u5mit t*o time% ei,ht to ten -a,e% -ro,re%% re-ort *ith -re%entation +urin, the %eme%ter?III an+ Seme%ter?I!. The %-ecific *ei,hta,e i% ,i)en to each -re%entation. //( The +i%tri5ution of *ei,hta,e of the )ariou% com-onent% of e)aluation for +i%%ertation *or7 %hall 5e a% follo*%E a( Re%earch Pro,re%% A%certainin, '0 time%( 5( Re%earch Pro;ect Pre%entation '$i+ Term( c( !i)a?!oice 'Uni)er%it& E6amination( Total /4 = /4 = <A = /AA = ea+ of the De-artment %hall 5e %u5mitte+ to the ea+ of the

/0( The e6ternal e)aluation of the +i%%ertation *or7 in Pha%e?I D Pha%e?II %hall 5e 5a%e+ on the -ro;ect re-ort %u5mitte+ to uni)er%it& an+ +urin, uni)er%it& e6amination he@%he %houl+ 5e -re%ent hi%@her +i%%ertation *or7 in -re%ence of e6-ert committee 'com-ri%in, of internal an+ e6ternal e6aminer a--ointe+ 5& uni)er%it&(.

),Pharma (P.) //, %orms !or Passing A can+i+ate mu%t ha)e %ecure+ a,,re,ate 4A= mar7% in each %eme%ter 'i.e 4AA total mar7% %tu+ent ha% to o5tain minimum 4A= mar7%G 04A mar7% for %eme%ter -a%%in,(. Thi% i% the minimum -a%%in, %tan+ar+ for %eme%ter. For in+i)i+ual %u5;ect minimum -a%%in, %tan+ar+ i% 3A= 'internal an+ e6ternal( mar7% for theor& or -ractical -ro)i+e+ he@%he ha%

%ecure o)erall 4A= mar7%. If he@%he o5tain le%% than 3A= 'internal an+ e6ternal( mar7% %o he@%he i% faile+ in -articular %u5;ect *hich *ill 5e con%i+ere+ a% a 5ac7lo, 'F(.

),Pharma (P.) /2, <ac;logs and Detention A can+i+ate at an& -oint of time can ha)e ma6imum A0 5ac7lo,%. If 5ac7lo,% are more than A0 than he@%he *ill not allo*e+ for ne6t %eme%ter an+ heH%he *ill 5e +etaine+ for one &ear. Imme+iate -re)iou% %eme%ter 5ac7lo,% *ill not 5e counte+ for +etention -ur-o%e. ),Pharma (P.) /1, Procedure !or $+arding o! .rade The total of the internal e6amination mar7% an+ en+ %eme%ter e6amination mar7% in each %u5;ect *ill 5e con)erte+ to a letter ,ra+e a% *ell a% to a ten?-oint %cale ',ra+e -oint( a% -er the follo*in, %chemeE Grading Scheme: )ange o! Mar;s (=) .rade .rade Point Description CA?/AA O /A Out%tan+in, FA?FC A AC <A?<C 8 AF BA? BC C A< 4A?4C D AB 3A? 3C E A4 I3A F A3

Fir%t cla%% +i%tinction Fir%t Secon+ Pa%% Fail *ith cla%% cla%% +i%tinction

Credit: The theor& an+ -ractical in each %eme%ter %hall 5e e)aluate+ 5a%e+ on cre+it %&%tem *hich *ill 5e ,i)en a% -er follo*in,E / hr o! Theory8Practical > / credit

.rade Point $6erage The %tu+entJ% -erformance in an& %eme%ter *ill 5e a%%e%%e+ 5& the Seme%ter Gra+e Point A)era,e 'SGPA(. Similarl&" hi%@her -erformance at the en+ of t*o or more con%ecuti)e %eme%ter% *ill 5e +enote+ 5& the Cumulati)e Gra+e Point A)era,e 'CGPA(. The SGPA an+ CGPA are +efine+ a% follo*%E

/1( S.P$ > ?Ci.i 8 ?Ci #here" Ci i% the num5er of cre+it% of %u5;ect 'i( Gi i% the Gra+e Point for the %u5;ect 'i( i G / to n" n G num5er of %u5;ect in the %eme%ter

/3( C.P$ > ?Ci.i 8 ?Ci #here" Ci i% the num5er of cre+it% of %u5;ect 'i( Gi i% the Gra+e Point for the %u5;ect 'i( i G / to n" n G num5er of %u5;ect of all %eme%ter% u-to *hich CGPA i% com-ute+

),Pharma (P.) /4, $+ard o! Degree E)er& can+i+ate of the -ro,ram *ho fulfil% the follo*in, criteria *ill 5e eli,i5le for the a*ar+ of the +e,reeE e@She %houl+ ha)e cleare+ all en+ %eme%ter an+ o)erall e)aluation% com-onent% in e)er& %u5;ect: an+ he@%he %houl+ ha)e %ecure+ a minimum CGPA of B.A at the en+ of the -ro,ramme. In a++ition to a5o)e" the %tu+ent ha% to com-lete the re9uire+ formalitie% a% -er the re,ulator& 5o+ie%" if an&. The %tu+ent *ho fail% to %ati%f& minimum re9uirement of CGPA *ill 5e allo*e+ to im-ro)e the ,ra+e% %o a% to %ecure a minimum CGPA for a*ar+ of +e,ree. Onl& late%t ,ra+e *ill 5e con%i+ere+.

),Pharma (P.) /3, $+ard o! Class A cla%% *ill 5e a*ar+e+ onl& after -a%%in, the final %eme%ter e6amination '3 th %eme%ter

e6amination(. A %tu+ent *ill 5e +eclare+ to -a%% the final e6amination lea+in, to a*ar+ of +e,ree of $a%ter in Pharmac& a% -er 5elo* mention ta5le -ro)i+e+ he@%he -a%%e% the e6amination in all the concerne+ %u5;ect% in each %eme%ter%. The cla%% a*ar+e+ to a %tu+ent in the -ro,ram i% +eci+e+ 5& the final CGPA a% -er the follo*in, %chemeE Di%tinctionE Fir%t cla%%E Secon+ Cla%%E FailE CGPA K<.4 CGPA KB.A D I<.4 CGPA K4.A D IB.A CGPA I4.A

),Pharma (P.) /4, Transcript The tran%cri-t i%%ue+ to the %tu+ent at the time of lea)in, the Uni)er%it& a% -er the norm% of uni)er%it& an+ re9ue%t 5& %tu+ent. The tran%cri-t *ill contain a con%oli+ate+ recor+ of all the cour%e% ta7en" cre+it% earne+" ,ra+e% o5taine+" SGPA" CGPA" cla%% o5taine+" etc.

The Follo+ing is the Structure and Scheme o! (2amination !or the T+o year M, Pharm (4 semester) courses o! di!!erent discipline,
P)@P@S(D ST)"CT")( F@) M$ST() &% P#$)M$CY D(.)(( (M, Pharm) C, ", S#$# "%&'()S&TYA *$D#*$% C&TY

First Semester M, Pharm ($ll Disciplines)Teaching Scheme (#ours8*ee;) Theory Sessional (2am Mar;s / 0 1 PG$P/A/@ PG$P/A/P PG$P/A0 PG$P///@/1/@/3/@/4/ PG$P///P@/1/P@/3/P@/4/P 3 PG$P//0@/10@/40 S-eciali.ation?II 3 /4 %ote-- T in+icate% TheoryB S in+icate% SeminarB and P in+icate% Practical 0 4 ? /2 AB 1: AB 1: 1A /:3 /.4 <A 243 1.A $o+ern Anal&tical Techni9ue% 8io%tati%tic% S-eciali.ation?I 3 0 3 ? ? 0 B ? B /A A0 /0 /A A0 /0 1A /4 1A #rs /.4 /.A /.4 "ni6ersity (2am Mar;s <A 14 <A #rs 1.A 0.A 1.A

(6

/AA 4A

/AA

/AA

13:

P)@P@S(D ST)"CT")( F@) M$ST() &% P#$)M$CY D(.)(( (M, Pharm) C, ", S#$# "%&'()S&TYA *$D#*$% C&TY
Second Semester M, Pharm ($ll Disciplines)Teaching Scheme (#ours8*ee;) Theory Sessional Exam Marks / 0 1 PG$P0A/ PG$P0A0 PG$P0//@01/@03/@04/ PG$P0//P@01/P@03/P @04/P 3 PG$P0/0@000@010@040 S-eciali.ation?I! 3 /4 %ote-- T in+icate% TheoryB S in+icate% SeminarB and P in+icate% Practical 0 4 ? 4 B 24 AB 24 1A /2: /.4 <A 27: 1.A /AA 4:: Dru, Re,ulator& A%-ect% D IPR Re%earch $etho+olo,& S-eciali.ation?III 3 3 3 ? ? 0 ? ? B 3 3 /0 3 3 /0 1A 1A 1A Hrs /.4 /.4 /.4 University Exam

(6al

Marks <A <A <A

Hrs 1.A 1.A 1.A /AA /AA /AA

P)@P@S(D ST)"CT")( F@) M$ST() &% P#$)M$CY D(.)(( (M, Pharm) C, ", S#$# "%&'()S&TYA *$D#*$% C&TY

Third Semester M, Pharm ($ll Disciplines)Teaching Scheme (#ours8*ee;) Theory Sessional Exam Marks / PG$P1//@11/@13/@14/ PG$P1//P@11/P@13/P@14/P 0 PG$P1A/ Di%%ertation Pha%e?I ? 4 %ote-- T in+icate% TheoryB S in+icate% SeminarB and P in+icate% Practical ? 2 /F 24 /F 1: /F 1: ? 1: ? ? 5: ? ? /:: S-eciali.ation?! 3 0 B /0 /0 1A Hrs /.4 University Exam

(6al

Marks <A

Hrs 1.A /AA

P)@P@S(D ST)"CT")( F@) M$ST() &% P#$)M$CY D(.)(( (M, Pharm) C, ", S#$# "%&'()S&TYA *$D#*$% C&TY

Fourth Semester M, Pharm ($ll Disciplines)Teaching Scheme (#ours8*ee;) Theory

(6al

Sessional Exam Marks / PG$P3A/ Di%%ertation Pha%e?II ? %ote-- T in+icate% TheoryB S in+icate% SeminarB and P in+icate% Practical ? 1A 1: 1A 1: 1A 1: ? Hrs ?

University Exam

Marks ? -

Hrs ? ? -

C " S#$# "%&'()S&TY *$D#*$% C&TY %ame o! the ProgramE $a%ter in Pharmac& 'All Di%ci-line( Total Credits accumulated at the end o! the program E //B Semester First Second Third Fourth Total Credits earned at the end o! the Program Credits 1: 24 1: 1: //4

C " S#$# "%&'()S&TY *$D#*$% C&TY %ame o! the ProgramE $a%ter in Pharmac& 'All Di%ci-line( Total Mar;s accumulated at the end o! the programE 73:: $ar7% S r. N o

Sem? e%ter

Theor&

Practical

Pro;ect #or7 'Di%%ertation(

Total $ar7%

Inter nal Mark s 1 2 3 4 First Seco nd Third Fo rt h 105 120 30 -

Exter nal Mark s 245 280 70 -

Total Mark s 350 400 100 -

Inter nal Mark s 60 30 30 -

Exter nal Mark s 140 70 70 -

Total Mark s 200 100 100 -

Inter nal Mar ks 60 !0

Exter nal Mark s 140 210

Total Mark s 200 300 550 500 400 300

Total Marks o" Theor# Exa$ination

850

Total Marks o" %ractical Exa$ination

400

Total Marks o" %ro&ect 'ork

500

1750

C " S#$# "%&'()S&TY

*$D#*$% C&TY

%ame o! Faculty- Pharmaceutical Science Proposed Sylla0i !or Master in Pharmacy Semester-& %ame o! Discipline/4( /B( /<( /F( /C(

Pharmaceutics Pharmaceutical Technology Cuality $ssurance Pharmaceutical $nalysis Pharmacology

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE All Di%ci-line Semester- &

%ame o! Su0DectE $o+ern Anal&tical Techni9ue% 'Theor&( Su0Dect CodeE PG$P/A/

T($C#&%. ('$E"$T&@% SC#(M(-Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam Hrs

(6alu

Marks Hrs Marks / PG$P/A/ $o+ern Anal&tical Techni9ue% 3 ? B /A /A 1A /.4 <A

/AA

@<F(CT&'(S--

0A( To ma7e %tu+ent% familiar *ith the -rinci-le% of mo+ern anal&tical techni9ue% an+ it%
a--lication in -harmac&

0/( To ,i)e trainin, in u%e of the techni9ue D it% a--lication% in +a& to +a& -ractice 00( To 5uil+ on the 5a%ic% learne+ at UG le)el D ,i)e late%t a+)ance% in the area 01( To ,i)e more %tre%% on a--lication 5a%e+ 7no*le+,e than
-o%%i5le in%trumentation 5a%e+ one

03( To ,i)e han+% on trainin, on u%e of a% man& +ifferent %o-hi%ticate+ in%trument% a%

P)()(C"&S&T(S--

04( $inimum t*o UG le)el cour%e% in Pharmaceutical anal&%i% 0B( A 8. Pharm. De,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent

C@")S( @"TE&%(-Sr, %o , 1 "' G 'isi0le spectroscopy- Theor&" chromo-hore% an+ their interaction *ith E$R" %ol)ent effect%" in%trumentation 'com-onent% an+ their function( D a--lication% AB Course Content #ours

inclu+in, multi?com-onent a%%a& an+ +eri)ati)e %-ectra. #oo+*ar+?Fie%er an+ Fie%er?Luhn rule% for calculatin, a5%or5ance ma6imum an+ inter-retation of %-ectra. 2 &n!rared spectroscopy- Intro+uction" 5a%ic -rinci-le%" in%trumentation 'com-onent% an+ their function(" %am-lin, techni9ue%" inter-retation of %-ectra an+ a--lication%. Theor& an+ a--lication% of FTIR"ATR an+ NIR. 3 %uclear Magnetic )esonance Spectroscopy- Fun+amental -rinci-le an+ theor& of -roton N$R" in%trumentation" %ol)ent%" chemical %hift" %-in?%-in cou-lin," cou-lin, con%tant" %-in?%-in +ecou-lin," -roton e6chan,e reaction%" %im-lification of com-le6 %-ectra" FT? N$R" 0D?N$R" a--lication% in -harmac& an+ inter-retation of %-ectra. /1C N$R S-ectro%co-&E Pea7 a%%i,nment%" off re%onance +ecou-lin," %electi)e -roton +ecou-lin," chemical %hift e9ui)alence" chemical %hift% an+ %-in cou-lin, an+ it% %tructural a--lication%. 4 Mass Spectroscopy- 8a%ic -rinci-le an+ in%trumentation" ion formation an+ t&-e" fra,mentation -roce%% an+ fra,mentation -attern" chemical ioni.ation ma%% %-ectro%co-& 'CI$S(" fiel+ ioni.ation $S 'FI$S(" Fa%t atom 5om5ar+ment $S 'FA8?$S(" matri6 a%%i%te+ la%er +e%or-tion@ ioni.ation $S '$ALDI?$S(" Inter-retation of %-ectra an+ a--lication in -harmac&" Surface Ioni.ation $S'SI$S(. 5 @ptical )otary Dispersion- Princi-le" Plain cur)e%" cur)e% *ith cotton effect" octant rule an+ it% a--lication% *ith e6am-le" circular +ichroi%m an+ it% relation to ORD. 6 Thermal Methods o! $nalysis E Thermoanal&tical techni9ue%E Differential Scannin, Calorimetr& 'DSC(" Thermo,ra)itr& 'TG(" Thermo mechanical anal&%i% 'T$A(E Princi-le% in%trumentation an+ a--lication% 'inclu+in, inter-retation of +ata( in -harmac&. 7 Chromatographic techniHues- Cla%%ification of chromato,ra-hic metho+% 5a%e+ on mechani%m of %e-aration. Theorie% of chromato,ra-hic %e-aration. Princi-le%" elution techni9ue%" in%trumentation" +eri)ati.ation an+ a--lication of GC" PLC" PTLC. Princi-le%" elution techni9ue%" a--lication% of ion e6chan,e an+ ion -air chromato,ra-h&" affinit& chromato,ra-h&" Si.e e6clu%ion chromato,ra-h&" chiral chromato,ra-h&" %u-er flui+ chromato,ra-h& 'SFC("UPLC" GC?$S" %hort column chromato,ra-h&" fla%h chromato,ra-h&" me+ium -re%%ure LC an+ LC?$S. /F A1 A1 AF /A AB

)adio analytical techniHues used in pharmaceuticals- I%oto-ic +ilution metho+%" Ra+ioimmunoa%%a&" ELISA etc.

A0

(lectrophoresis- Theor& an+ -rinci-le%" cla%%ification%" in%trumentation" mo)in, 5oun+ar& electro-hore%i%" Mone Electro-hore%i% 'ME(" I%oelectric focu%in, 'IEF( an+ a--lication%.

A0

10

())lication

o" Trans$ittance Electron Microsco)# *TEM+ and

A0

Scannin, Electron Microsco)# *SEM+Total BA

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE All Di%ci-line Semester- & %ame o! Su0DectE $o+ern Anal&tical Techni9ue% 'Practical( Su0Dect CodeE PG$P/A/P
Module-/- U!@!i%i5le %-ectrum %cannin, of a fe* or,anic com-oun+% for U!? a5%or-tion an+ correlation% of %tructure% an+ i%o%5e%tic -oint in ca%e of mi6ture%. Module-2- Effect of %ol)ent% an+ - on U! %-ectrum of +ru,% Module-1- Simultaneou% e%timation of com5ination formulation% 'minimum of 3 e6-eriment%(E e.,. !itamin%" Oral anti+ia5etic%" NSAID%" Antimicro5ial%" Antihi%tamine%" Antih&-erten%i)e etc. Module-4- E6-eriment% 5a%e+ on the a--lication of +eri)ati)e %-ectro%co-&. Module-3- E6-eriment% 5a%e+ on PLC 'I%ocratic an+ Gra+ient elution( techni9ue%. Module-4- Inter-retation of +ru,% 5& IR %-ectra Module-5- #or7%ho- of %-ectro%co-&E 'U!" IR" N$R" $ASS( %tructural eluci+ation of fe* com-oun+% Module-7- Se-aration of -rotein +ru, %u5%tance% 5& electro-hore%i% Module-9- U%e of fluorimeter for anal&%i% of Pharmaco-oieal com-oun+%. Module-/:- E6-eriment% of Chromato,ra-h&. 'a( Thin La&er Chromato,ra-h&" '5( Pa-er Chromato,ra-h&. Module-//- An& other rele)ant e6-eriment% 5a%e+ on theor&.

E($)%&%. @"TC@M(S--

0<( At the en+ of the cour%e" the %tu+ent *ill 5e a5le to un+er%tan+ the fun+amental conce-t
of mo+ern anal&tical techni9ue%" *hich i% im-ortant for 9ualitati)e a% *ell a% 9uantitati)e anal&%i% of +ru, %u5%tance% an+ +ru, -ro+uct.

T($C#&%.

E($)%&%. M(T#@D@E@.Y--

0F( Facult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia
-ro;ector.

<@@IS )(C@MM(%D(D--

0C( A. . 8ec7ett" >.8. Stenla7e N Practical Pharmaceutical Chemi%tr&" Part I an+ Part II 'C8S Pu5li%her% Delhi 1A( Chromato,ra-hic Anal&%i% of Pharmaceutical%" A. >ohn" A+amo)ic%" C&to,an Cor-oration" Princeton" N>. 1/( Clar7eJ% Anal&%i% of Dru,% an+ Poi%on%" A.C.$offat" $. Da)i+ O%%elton" 8rain #i++o-" L. Y. Galichet. 1r+ e+ition" Pharmaceutical Pre%%. 10( Colorimetric $etho+% of anal&%i%? F. D. Snell an+ C. T. Snell '!an No%tran+ Reinhol+ Com-an&" N.Y.(. 11( an+5oo7 of In%trumental techni9ue% for anal&tical chemi%tr&" Fran7 Settle"/ %t e+ition" Pear%on e+ucation" Sin,a-ore. 13( PTLC N 2uantitati)e Anal&%i% of Pharmaceutical Formulation% N P. D. Sethi. 14( I+entification of Dru,% an+ Pharmaceutical Formulation% 5& Thin La&er Chromato,ra-h&" 0n+ E+ition" P. D. Sethi" C8S Pu5li%her% an+ Di%tri5uter%" Ne* Delhi. 1B( In%trumental $etho+% of Anal&%i% N #illar+" $erritt" Dean" C8S" Delhi.

1<( In%trumental $etho+% of Chemical Anal&%i%" 8.L. Sharma" Goel Pu5lication ou%e" $eerut" In+ia. 1F( In%trumental $etho+% of Chemical Anal&%i%" G. #. E*in," $cGra* Co" NY. 1C( Li9ui+ Chromato,ra-h& N $a%% S-ectrometr&" #. $. A. Nie%%en" >. !an Der Greef" !ol. 4F. 3A( $o+ern $etho+% of Pharmaceutical Anal&%i%" !ol /" 0" RE Schirmer" Fran7lin 8oo7 Co" PA. 3/( N$R %-ectro%co-& '8a%ic Princi-le%" conce-t% an+ a--lication in Chemi%tr&( eral+ Gunther '>ohn #ile& an+ Son%(" NY.. 30( Or,anic S-ectro%co-& N #illiam Lem-" 1r+ E+ition. 31( P.D. Sethi N 2uantitati)e Anal&%i% of Dru,% in Pharmaceutical formulation% '!8S Pu5li%her%" Delhi(. 33( Pharmaceutical Anal&%i% N $o+ern $etho+% N Part A" Part 8" >ame% #. $un%on 0AA/. 34( Practical Pharmaceutical Chemi%tr&" Part t*o" A. . 8ec7ett D >. 8. Stenla7e N 3 th e+ition. 3B( Princi-le% of In%trumental Anal&%i% 5& Don,la% A. S7oo," >ame%" >. Lear&" 3th E+ition. 3<( Remin,tonJ% Pharmaceutical Science%" >. P. Remin,ton" $ac7 Pu5. Co." Penn%&l)ania. 3F( S-ectrometric i+entification of Or,anic Com-oun+%" Ro5ert. $. Sil)er%tein" 8a%%eler" $orril '>ohn #ile& an+ Son%. N.Y(. 3C( S-ectro%co-ic i+entification of or,anic com-oun+%. >ohn D&er" #ill&" NY. 4A( S-ectro%co-& of Or,anic Com-oun+% 5& P. S. Lal%i. ill 8oo7

4/( Techni9ue% an+ Practice of Chromato,ra-h& N Ra&mon+ P. #. Scott" !ol. <A. 40( Te6t 5oo7 of Pharmaceutical Anal&%i%" L. A. Connor%" 1r+ E+." >ohn #ile& D Son%" Ne* Yor7. 41( Unite+ State% Pharmaco-oeia?0<'NF?00(" 0AA3" Unite+ State of Pharmaco--eal con)ention" INC" /0BA/ T*in5roo7 Par7*a&" Roc7)ille" $D 0AF40. 43( 8riti%h Pharmaco-oeia" 0AA3" The 8riti%h Pharmaco-oeia commi%%ion office" $ar7et To*er" Nine Elm% Lane" Lon+on. 44( In+ian Pharmaco-oeia?0AA<" In+ian -harmaco-oeia commi%%ion" Sector?01" Ra; Na,ar" Gha.ia5a+.
(-)(S@")C(S--

4B( ***.Dascoinc.com@ 4<( ***.%%i.shimadJu.com 4F( ***.-er7inelmer.com 4C( ***.-henomene6.com

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE All Di%ci-line Semester- & %ame o! Su0DectE 8io%tati%tic% 'Theor&( Su0Dect CodeE PG$P/A0
T($C#&%. ('$E"$T&@% SC#(M(-Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam

(6alu

Marks Hrs Marks / PG$P/A0 8io%tati%tic% 0 ? ? A0 A0 /4 / 14

Hrs

4A

@<F(CT&'(SBA( To e6-lain %tu+ent% *ith )ariou% Stati%tical Techni9ue% u%e+ to +ra* conclu%ion% in E6-erimental Re%earch. B/( To em-ha%i.e the u%e of the%e Techni9ue% to a++re%% the -ro5lem% an+ i%%ue% ari%in, in the +i%ci-line of Pharmac& an+ to fin+ their %olution% u%in, Stati%tical Soft*are. P)()(C"&S&T(S-B0( /A O 0 le)el mathematic% 7no*le+,e. B1( 8" Pharm. De,ree from an& in%titution a--ro)e+ 5& AICTE or it% e9ui)alent. C@")S( @"TE&%(Sr, %o :/ C@")S( C@%T(%TS &ntroductionRele)ance an+ the %co-e of Stati%tic%. Difference 5et*een PDe%cri-ti)eJ an+ PInferentialJ Stati%tic%: Relation%hi:2 5et*een them Test o! hypothesis Conce-t% of h&-othe%i% te%tin, an+ t&-e% of error%. Point an+ inter)al e%timation inclu+in, fi+ucial limit%" t?te%t" Chi %9uare te%t%" f?te%t" M?te%t. %on parametric test li;- Si,n te%t" $ann?#hitne& U te%t" #ilco6on %i,n ran7 :1 te%t" Lru%7al *alli% te%t Correlation and regressionIntro+uction an+ Theor&" +ifferent metho+ of correlation ',ra-hical metho+" Per%onJ% -ro+uct moment" correlation coefficient%" S-earman ran7 correlation. )egressionE Re,re%%ion line" Determination of Re,re%%ion coefficient%" $ulti-le re,re%%ion :4 anal&%i% $%@'$ Intro+uction" One #a& ANO!A" T*o *a& ANO!A an+ itJ% %tati%tical inference% :3 :5 // #)S :2

:3

(2perimental design in clinical trialsB Parallel an+ cro%%o)er +e%i,n%. Stati%tical te%t for 5ioe9ui)alence. Do%e re%-on%e %tu+ie%

:4

:4

&ntroduction to common so!t+are Total

:/ 1:

E($)%&%. @"TC@M(SB3( Stu+ent% *ill a5le to i+entif&" anal&.e an+ %ol)e -ro5lem% relate+ to 5io%tati%tic% u%in, %tati%tical %oft*are. B4( Stu+ent% can a--l& 5io%tatic% a--lication in or+er to un+er%tan+ )ariou% -harmaceutical -roce%% )aria5le%" un+er%tan+ %i,nificance effect on -arameter% in clinical trial% T($C#&%. E($)%&%. M(T#@D@E@.Y-

BB( Lecture% *ill 5e ta7en in cla%% room *ith the ai+ of multi?me+ia -re%entation% @ 5lac7 5oar+ or mi6 of 5oth. B<( A%%i,nment% 5a%e+ on the cour%e content *ill 5e ,i)en at the en+ of the to-ic. <@@IS )(C@MM(%D(D-BF( Stanfor+ 8olton" Charle% 8on '0AA3(" Pharmaceutical Stati%tic%" Practical an+ Clinical
A--lication% 'Fourth re). e+( $arcel De77er" Inc

BC( Do*+&" S." an+ #ear+en" S. '/CC/(" Stati%tic% for Re%earch '0n+ e+.(" Ne* Yor7E >ohn
#ile&.

<A( Freun+" R. >." an+ #il%on" #. >. '/CC<(" Stati%tical $etho+% 're). e+.(" San Die,o" CAE
Aca+emic Pre%%

</( $iller" R. G." Efron" 8." 8ro*n" 8. #." an+ $o%e%" L. E. 'e+%.( '/CFA(" 8io%tati%tic%
Ca%e5oo7" Ne* Yor7E >ohn #ile&.

<0( Steel" R. G. D." an+ Torrie" >. . '/CFA(" Princi-le% an+ Proce+ure% of Stati%tic%E A
8iometrical A--roach '0n+ e+.(" Ne* Yor7E $cGra*? ill.

<1( #ool%on" R. F. '/CF<(" Stati%tical $etho+% for the Anal&%i% of 8iome+ical Data" Ne*
Yor7E >ohn #ile&.

<3( #ac7erl& DD" $en+enhall #" Scheaffer RL. $athematical Stati%tic% *ith A--lication%"
<th e+ition" 0AAF" Du65ur& Pre%%" USA

<4( Pianta+o%i S. '0AA4(" Clinical Trial% a $etho+olo,ical Per%-ecti)e" 0n+ e+ition. >ohn
#ile& D Son%.

<B( Senn S. Cro%%?o)er trial% in clinical re%earch" 0n+ e+ition. #ile&" 0AA0.
>enni%on C. an+ 8.#. Turn5ull. Grou- %e9uential metho+% *ith a--lication% to clinical trial%. Cha-man D all" /CCC.C.

U. S A UNI!ERSITY

#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutic% D Pharmaceutical Technolo,& DisciplineE /. Pharmaceutic% 0. Pharmaceutical Technolo,& Semester- & %ame o! Su0DectE Fun+amental of Formulation D Pro+uct De)elo-ment 'Theor&( 'S-eciali.ation?I( Su0Dect CodeE PG$P///
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory

(6aluati

Sessional Exam

University Exam Hrs

Marks Hrs Marks / PG$P/// Fun+amental of Formulation D Pro+uct De)elo-ment 3 0 B /0 /0 1A /.4 <A

M /AA

@<F(CT&'(<<( To un+er%tan+ formulation +e)elo-ment conce-t" li7e -reformulation" e6ci-ient%" %ta5ilit& an+ +i%%olution in or+er to +e)elo- %afe" effecti)e an+ %ta5le +o%a,e% form. <F( To ,i)e trainin, at a+)ance+ le)el in -reformulation %tu+ie% of +ru,% D other re9ui%ite a%-ect%. <C( To ,i)e -ractical trainin, to %tu+ent% in the%e a%-ect%.

P)()(C"&S&T(SE? FA( 8a%ic 7no*le+,e in Pharmaceutic%. F/( 8. Pharm. De,ree from an& in%titution a--ro)e+ 5& AICTE or it% e9ui)alent. C@")S( @"TE&%(Sr, %o :/ Pre!ormulation C@")S( C@%T(%TS dosages !orm design aspects#@")S :4

Intro+uction" ,oal% of -reformulation" Detaile+ %tu+& of -h&%ical" chemical an+ -harmaceutical -arameter% influencin, formulation of +ru,%. Com-ati5ilit& te%t%. Si,nificance an+ metho+% for e)aluation of +ru,?e6ci-ient" e6ci-ient ?e6ci-ient an+ +ru, container%@clo%ure% :2 interaction% an+ incom-ati5ilitie%. Polymorphism in pharmaceutical solidsA--lication of -ha%e rule to the characteri.ation of -ol&mor-hic %&%tem%" %tructural a%-ect of -ol&mor-hi%m" h&+rate% an+ %ol)ent%" ,eneration of -ol&mor-h%" h&+rate%" %ol)ate% an+ amor-hou% %oli+%" metho+% for the characteri.ation of -ol&mor-h% an+ %ol)ate%" effect :3

of -ol&mor-hi%m on %olu5ilit& an+ +i%%olution rate" effect of -harmaceutical -roce%%in, on +ru, -ol&mor-h% an+ %ol)ate%" im-act :1 of -ol&mor-hi%m on 9ualit& of l&o-hili.e+ -ro+uct%. Partition Coe!!icient Pharmaceutical %i,nificance of -artition coefficient" correlation *ith in?)i)o -erformance" techni9ue% to e%timate lo, P )alue%" %ha7e fla%7 metho+" choice of %ol)ent %&%tem%" chromato,ra-hic +etermination" theoretical com-utation u%in, an%ch D Leo@Re77er -rinci-le" effect :4 of )ariou% )ariant% li7e tem-erature" - " etc. on -artition coefficient. (2cipientsGeneral con%i+eration% of e6ci-ient% u%e+ in formulation% an+ factor% ,o)ernin, %election. Compati0ility issues regarding e2cipients- +ru,?e6ci-ient% an+ e6ci-ient e6ci-ient" e6ci-ient%?-ac7a,e interaction% Sa!ety and regulatory issues o! e2cipients &nternational patented e2cipients, Im-lication of 9uantitati)e %election of each e6ci-ient in -ro+uct +e)lo-ment. Study o! no6el e2cipientsSu-er+i%inte,rant%" +irectl& com-re%%i5le an+ %-ra& +rie+ +iluent%" film coatin, material%" %olu5ili.in, a,ent% li7e %urfactant%" C&clic Gluco%e Pol&mer%" -ol&meric e6ci-ient% for controlle+ relea%e a--lication%" Im-ro)e+ e6ci-ient% functionalit& 5& co -roce%%in," :3 Stan+ar+i.ation of e6ci-ient% <iomaterialsT&-e%" a--lication% of 5iomaterial% in -harmaceutical formulation% D me+icine" %afet& con%i+eration% of 5iomaterial%" mechani%m of :4 5io+e,ra+ation. Solu0ility and Solu0iliJation De)elo-ment of theoretical relation%hi-% of -ro,no%tic rele)ance" techni9ue% of %olu5ili.ation of +ru,% inclu+in, %urfactant %&%tem%" co?%ol)ent%" %oli+ +i%-er%ion%" com-le6ation" inclu%ion com-le6e% :7 :4 :7 :3

*ith reference to :5

c&clo+e6trin%" t&-e% of c&clo+e6trin%" their :7

-harmaceutical a--lication% an+ chemical mo+ification%. Dissolution itKs testing(a) Im-ortance" o5;ecti)e%" e9ui-ment%" (0) 8iolo,ical cla%%ification %&%tem '8CS(: it% %i,nificance on +i%%olution %tu+& an+ a--lication in +o%a,e form +e)elo-ment. (c) Selection of +i%%olution me+ia an+ con+ition%. (d) Com-ari%on of +i%%olution -rofile 5& mo+el in+e-en+ent '%imilarit& an+ +i%%imilarit& factor( an+ +e-en+ent metho+%. Sta0ility o! drug dosage !ormsQ De,ra+ation of +ru, in %oli+ %tate D %oli+ +o%a,e form%" %ta5ili.ation metho+%" im-ortance of %ta5ilit& in+icatin, a%%a& in %ta5ilit& e)aluation" %ta5ilit& e)aluation of +i%-er%e %&%tem%. Q 8rief intro+uction to FDA an+ # O ,ui+eline%. Detail %tu+& of IC ,ui+eline% '2/A" 'R0(" 2/8" 2/C" 2/D" 2/E" 2/F" 24C(. Q Linetic -rinci-le% a--lie+ for %ta5ilit& e)aluation an+ their a--lication% in -re+ictin, %helf life an+ half life of -harmaceutical formulation%. Im-ortance of accelerate+ %ta5ilit& %tu+&. #er0al Product De6elopment 8ac7,roun+ an+ -re%ent %cenario" formulation con%i+eration%" ma;or hur+le% an+ challen,e%" future -ro%-ect%. Documentation Im-ortance of +ocumentation" %tatutor& re9uirement% an+ -roce+ure for +ocumentation" critical e6amination of +ocument%.

:7

:7

:9

:1

/:

:3

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutic% D Pharmaceutical Technolo,& DisciplineE /. Pharmaceutic% 0. Pharmaceutical Technolo,& Semester- & %ame o! Su0DectE Fun+amental of Formulation D Pro+uct De)elo-ment 'Practical( 'S-eciali.ation?I( Su0Dect CodeE PG$P///P

Detailed Sylla0us (Practical)- To illu%trate the to-ic% inclu+e+ un+er theor&

E($)%&%. @"TC@M(F0( To +e)elo- the a5ilit& to effecti)el& a--l& 7no*le+,e of e6ci-ient%" +o%a,e form%" -reformulation" 9ualit& im-ro)ement%" an+ +ocumentation of -harmaceutical -ro+uct% an+ +ru, +eli)er& %&%tem%.

T($C#&%.

E($)%&%. M(T#@D@E@.Y-

F1( Throu,h +i%cu%%ion in a cla%%?room" an+ -erformin, e6-eriment% relate+ to Pro+uct +e)elo-ment %tu+ie%.

<@@IS )(C@MM(%D(D-/. Dru, Sta5ilit&" >. T. Car%ten%en" $arcel De77er" Ne* Yor7 0. Theor& D Practice of In+u%trial Pharmac&" L. Lachman" !ar,he%e Pu5lication" 8om5a&. 1. $o+ern Pharmaceutic%" G.S. 8an7er an+ C.T. Rho+e%" $arcel De77er" NY. 3. Ph&%ical Characteri.ation of Pharmaceutical Soli+%" NY. 4. Ph&%ical Pharmac&" A. $artin" Lea an+ Fe5i,er" Phila+el-hia. B. Pharmaceutical +i%%olution te%tin," U.!. 8ana7er" $arcel De77er" Inc." Ne* Yor7. <. Pharmaceutical Do%a,e Form% E Parenteral $e+ication%" A)i% L. E." Leon Lachman an+ . Lie5erman" $arcel De77er" Ne* Yor7 F. Pharmaceutical Do%a,e Form% E ta5let%" Lier5erman . A. an+ Leon Lachman" " $arcel De77er" Ne* Yor7 C. Oral li-i+ 5a%e+ formulation%: D.>. au%%" Informa ealthcare" Ne* Yor7 /A. Pol&mor-hi%m in Pharmacetucial %oli+%E .G. 8rittain" $arcel De77er" Ne* Yor7 //. 8io+e,ra+a5le -ol&mer% a% +ru, +eli)er& %&%tem%" e+ite+ 5& $.Cha%in" R.lan,er" $arcel De77er" Ne* Yor7. //. an+5oo7 of Preformulation%" S. L. Nia.i" Informa ealthcare" Ne* Yor7. /0. Pharmaceutical Preformulation% D Formulation" e+ite+ 5& $ar7% Gi5%on" Inter-harm@CRC" 8oca Raton" Flori+a" USA. . G. 8rittain" $arcel De77er"

(-)(S@")C(S-F3( +++,!da,go6,org F4( On line ;ournal%

C, ", S#$# "%&'()S&TY

*$D#*$%C&TY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutic% D Pharmaceutical Technolo,& DisciplineE /. Pharmaceutic% 0. Pharmaceutical Technolo,& Semester- & %ame o! Su0DectE 8io-harmaceutic%" Pharmaco7inetic% D $etho+% in Dru, E)aluation 'Theor&( 'S-eciali.ation?II( Su0Dect CodeE PG$P//0
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam Hrs

(6aluatio

Marks Hrs Marks / PG$P//0 8io-harmaceutic%" Pharmaco7inetic% D $etho+% in Dru, E)aluation 3 0 ? AB AB 1A /.4 <A

Ma /AA

@<F(CT&'(S-FB( To Stu+& the a5%or-tion" meta5oli%m" +i%tri5ution an+ e6cretion of +ru,%. The -rimar& ,oal of the cour%e relate+ to -harmaco7inetic% i% to -ro)i+e a conce-tual an+ 9uantitati)e 5ac7,roun+ in -harmaco7inetic theor& an+ a--lication%. Thi% *ill 5e in+i%-en%a5le to -ur%ue %tu+ie% in clinical -harmaco7inetic% an+ *hich in tern% hel- in +ru, +eli)er& %&%tem +e%i,n an+ +e)elo-ment of -harmaceutical formulation%.

F<( To familiar %tu+ent% a5out e)aluation of +ru,% 5& )ariou% metho+olo,& in -harmac&.

P)()(C"&S&T(S-. 8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent

C@")S( @"TE&%(Sr. No $DM( Characteristics o! drug1 Dru, A5%or-tionE General con%i+eration" a5%or-tion @ +ru, 01 tran%-ort mechani%m%" role of %or-tion -romoter%" factor% affectin, a5%or-tion" a5%or-tion of +ru, of throu,h route% other then oral" in? )itro" in?%itu" in?)i)o an+ cell line 'Caco N 0( %tu+& metho+% of +eterminin, a5%or-tion. 2 Dru, Di%tri5utionE Factor% affectin, +ru, +i%tri5ution" -rotein D ti%%ue 5in+in," A--arent )olume of +ru, +i%tri5ution 3 Dru, $eta5oli%m '8iotran%formation(E 8iotran%formation" factor% affectin, 5iotran%formation" Pha%e I D Pha%e?II reaction% 4 Dru, E6cretionE Glomerular filtration" tu5ular %ecretion" tu5ular 02 rea5%or-tion" Factor% affectin, +ru, e6cretion. Pharmaco;inetics1 One com-artment an+ t*o com-artment% o-en mo+elE i.). 5olu% a+mini%tration" i.). infu%ion" e6tra )a%cular a+mini%tration 2 $ulticom-artment mo+el 3 A--lication of Pharmaco7inetic%E ne* +ru, +e)elo-ment" De%i,n of +o%a,e form% an+ no)el +ru, +eli)er& %&%tem%" Ca%e %tu+ie% 5a%e+ on -harmaco7inetic -rinci-le% /A AF C@")S( C@%T(%TS #)S

4 Determination of )ariou% -harmaco7inetic -arameter% 5 A5%or-tion rate con%tant" elimination rate con%tant" 5iolo,ical half life" = +ru, 6 meta5oli.e+" a--arent )olume of +i%tri5ution" e6cretion rate con%tant" Clearance ' inclu+in, the conce-t of renal D non?renal clearance(" Linetic% of -rotein 5in+in, an+ other Pharmaco7inetic -arameter% 7 Soft*are% u%e+ for +etermination of -harmaco7inetic -arameter% Pharmaco;inetics o! Multiple Dosing8 A+;u%tment of +o%a,e in renal D he-atic im-airment" in+i)i+uali.ation of thera-&" thera-eutic +ru, monitorin," Linetic% 03 of %u%taine+ relea%e %on-linear Pharmaco;ineticsCau%e% 04 of non?linearit&" e%timation of )ariou% -arameter% an+ AB 5ioa)aila5ilit& of +ru,% that follo* non?linear 7inetic% <ioa6aila0ility <ioeHui6alenceO5;ecti)e% of 5io?a)aila5ilit& D 5ioe9ui)alence %tu+ie%" $ea%urement% of 5io?a)aila5ilit&" Conce-t of 8ioe9ui)alence" E6-erimental De%i,n% in 8ioe9ui)alence %tu+& 'Cro%% o)er" Latin S9uare" 8alance incom-lete 5loc7 +e%i,n etc(" Re,ulator& a%-ect% of 5io?a)aila5ilit& an+ 5ioe9ui)alence %tu+ie% for con)entional +o%a,e form% an+ controlle+ +ru, +eli)er& 05 %&%tem% &n-6itro &n-6i6o Correlation (&'&'C)Conce-t" $etho+% of e%ta5li%hin, I!I!C" Factor% effectin, I!I!C. A--lication of I!I!C for 5io*ai)er% of imme+iate relea%e +o%a,e form%. 06 07 I!I!C for Su%tain Relea%e an+ controlle+ relea%e +o%a,e form% Gui+eline for the u%e an+ care of la5orator& animal%. To2icological e6aluation o! ne+ chemical entitiesAcute" %u5 acute an+ chronic to6icit& %tu+ie%" terato,enicit&" muta,enicit& 08 an+ carcino,enic %tu+ie%. Techni9ue% in the e%timation of en.&me an+ the en+o,enou% %u5%tance% in the 5o+& flui+% in -h&%iolo,ical an+ -atholo,ical con+ition. A0 A0 A0 A4 A0

0!

<iological e6aluation o! !ollo+ing classes o! drugsE 'De)elo-ment of mo+el% for +i%ea%eE in )i)o mo+el% @ in )itro mo+el% @ cell line %tu+ie%(. Anal,e%ic" antiinflammator&" antie-ile-tic" anti+ia5etic" antifertilit&" antih&-erten%i)e" anti+&%li-i+aemic" anticancer" antia%thmatic" anti)iral" anti5acterial" antifun,al" anti-ara%itic" antiulcer" he-ato-rotecti)e" immunomo+ulator&. <ioassay o! 6arious hormones, Ne* a--roach in +ru, +i%co)er& ' i,h throu,h-ut Screenin,? TS(. Goo+ Clinical Practice 'GCP(E IC ,ui+eline% 'EBR/( Total

/F

10 11

A0 A1 BA

E($)%&%. @"TC@M(SFF( Stu+ent% *ill 5e a5le to -re+ict the effect% of )ariou% -h&%icochemical" 5iochemical" -h&%iolo,ical an+ -atholo,ical -roce%%e% on the 7inetic% an+ e6tent of +ru, a5%or-tion" +i%tri5ution" an+ elimination. FC( Stu+ent *ill 5e a5le to learn the 5a%ic techni9ue% to e)aluate +ru,% u%in, )ariou% animal mo+el% for +ifferent -atholo,ical con+ition%. T($C#&%. E($)%&%. M(T#@D@E@.Y-

Facult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia -ro;ector

<@@IS )(C@MM(%D(D-/. Pharmaco7inetic%" $ Gi5al+i" $arcel De77er" Inc." Ne* Yor7. 0. Remin,tonJ% Pharmaceutical Science%" $ac7 -u5li%hin, com-an&" Penn%&l)ania. 1. 8io-harmaceutic% an+ Pharmaco7inetic%? A Treati%e" D.$. 8rahman7ar an+ Sunil 8. >ai%*al" !alla5h Pra7a%han Pitam-ura" Delhi. 3. Clinical Pharmaco7inetic%" Conce-t% an+ A--lication%" $. Ro*lan+ an+ T. N. To.er" Li--incott #illiam% D #il7in%" Phila+el-hia

4. 8io-harmaceutic% an+ Clinical Pharmaco7inetic%? An intro+uction: Ro5ert. E. Notari" $arcel De77er Inc" Ne* Yor7 B. Enc&clo-e+ia of Pharmaceutical Technolo,&" >ame% S*ar5ric7 an+ C.8o&lan" $arcel De77er Inc" Ne* Yor7" <. Pharmaceutical +i%%olution te%tin," U.!. 8ana7er" $arcel De77er" Inc." Ne* Yor7. F. The Unite+ State% Pharmaco-oeia?0< 'NF?00("0AA3" Unite+ State of Pharmaco--eal con)ention" INC" /0BA/ T*in5roo7 Par7*a&" Roc7)ille" $D 0AF40. C. A--lie+ 8io-harmaceutic% an+ -harmaco7inetic%" Leon Shar,el" $c Gra* ill" /A. Pharmaco7inetic%" #ellin, an+ T%e" $arcel De77er" Inc." Ne* Yor7. //. 8io-harmaceutic% an+ Clinical Pharmaco7inetic%" Nia.i" Prentice all" Lon+on /0. Do%e fin+in, in Dru, De)elo-ment" N. Tin," S-rin,er" U.L. /1. Dru, +i%-o%ition D Pharmaco7inetic%" S. . Curr&" Pharma $e+ Pre%% " &+era5a+ /3. Intro+uction of 8io-harmaceutic% D Pharmaco7inetic%" Na,ar%en7ar" Nirali Pra7a%han" Pune. /4. Te6t5oo7 of 8io-harmaceutic% D Pharmaco7inetic%" >a)e+ Ali" R. L. Lhar an+ Al7a Ahu;a" 8irla Pu5lication" Delhi. /B. 8io-harmaceutic% D Pharmaco7inetic%" !en7ate%h*arlu" In+ia /<. Dru, +i%co)er& an+ e)aluationE Pharmacolo,ical a%%a&%" e+ition" 0AA0. /F. Screenin, metho+% in -harmacolo,& !ol?/ D 0" Ro5ert Arnol+ Turner" /C</" Aca+emic Pre%%. /C. Fun+amental of e6-erimental -harmacolo,&" $.N. Gho%h" C</" Scientific 8oo7 A,enc&. 0A. 2ualit& control of her5al +ru,%E an a--roach to e)aluation of 5otanical%" Pulo7 L. $u7her;ee" 0AA0" 8u%ine%% hori.on%. 0/. Rele)ant article% from ;ournal%. . Gerhar+ !o,el" 0n+ . P. Ti-ni% an+ $. S.

00. Dru, 5io%creenin,E +ru, e)aluation techni9ue% in -harmacolo,&" Emmanuel 8. Thom-%on" /CCA" !C -u5li%her. 01. Dru, a5%or-tion %tu+ie%E in %itu" in )itro an+ in %ilico mo+el%" 8& Car%ten Ehrhar+t" L*an,?>in Lim" 0AAF.

(-)(S@")C(S-/. ***.f+a.,o) 0. htt-E@@***.ich.or,

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE 2ualit& A%%urance '2.A( Semester- & %ame o! Su0DectE $etho+ of Dru, E)aluation D Clinical Re%earch 'Theor&( 'S-eciali.ation?I( Su0Dect CodeE PG$P/1/
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam

(6aluation Sc

Sess Exa Mark s /A A 1A

Mark Hrs Marks Hrs s / PG$P/1/ $etho+ of Dru, E)aluation D Clinical Re%earch 3 0 B /0 /0 1A /.4 <A

@<F(CT&'(S--

CA( To train %tu+ent% a5out )ariou% 5iolo,ical e)aluation metho+% D the %i,nificance of %uch
te%t%

C/( To im-art 7no*le+,e a5out official @ non?official metho+% of e)aluation for a *i+e ran,e
of -harmaceutical +o%a,e form%

C0( To ,i)e *i+e e6-o%ure to %tu+ent% in the area of Ne* Chemical Entit& -re?clinical
e)aluation% D relate+ area%

C1( To ,i)e them trainin, in carr&in, out %ome of the%e techni9ue% in the la5orator&

P)()(C"&S&T(S--

C3( At lea%t t*o cour%e% each in Pharmaceutic% D 5iolo,& @ micro5iolo,& or relate+

5iolo,ical %u5;ect% at UG le)el

C4( A 8. Pharm. +e,ree from an& in%titution a--ro)e+ 5& AICTE or it% e9ui)alen

C@")S( @"TE&%(-Sr, %o Course Content #ours

8iolo,ical Stan+ar+i.ationE General Princi-le%" Sco-e D limitation% of 8ioa%%a&% 8io? a%%a&% of %ome Official Dru,%.

A3

2 1

Sterilit& Te%t%E $etho+olo,& D Inter-retation. P&ro,en ? chemi%tr& an+ -ro-ertie% of 5acterial -&ro,en% an+ en+oto6in%.$echani%m% of action of -&ro,en%. Pharmaceutical a%-ect%" -&ro,en te%t of IP com-are+ to that of 8P D USP. Inter-retation of +ata" Com-ari%on of LAL an+ other -&ro,en te%t%.

A3 A4

Anal&%i% of +ru,% from 5iolo,ical %am-le% inclu+in," %election of 5iolo,ical %am-le" e6traction of +ru,% 5& )ariou% metho+% a% LLE" SPE an+ $em5rane filtration.

A4

$icro5iolo,ical Limit Te%t%" Te%t% for effecti)ene%% of antimicro5ial -re%er)ati)e%.

AB

Ra+io immunoa%%a&E General -rinci-le%" %co-e an+ limitation%" ra+io immunoa%%a& of %ome +ru,% li7e in%ulin" +i,itali% etc.

A3

Preclinical Dru, E)aluation" acute" %u5 acute an+ chronic to6icit& %tu+ie%" LD4A DED4A +etermination" e)aluation of com-oun+ for it% 5iolo,ical acti)it&" %tu+& of %-ecial to6icitie% li7e terato,enicit& an+ muta,enicit&.

A<

Clinical Re%earchR a. Clinical Re%earch Protocol%" o5;ecti)e an+ -rotocol +e%i,n. 5. el%in7i +eclaration" US?FDA D IC ,ui+eline for Clinical trial% for +ru,% an+ +o%a,e form%" re)ie*% an+ a--ro)al of Clinical Stu+&. c. Goo+ Clinical Practice%. <ioa6aila0ility-- O5;ecti)e% an+ con%i+eration in 5io?a)aila5ilit& %tu+ie%" Conce-t of e9ui)alent%" $ea%urement% of 5io?a)aila5ilit&" Determination of the rate of a5%or-tion" 8ioe9ui)alence an+ it% im-ortance" Re,ulator& a%-ect% of 5io?a)aila5ilit& an+ 5ioe9ui)alence %tu+ie% for con)entional +o%a,e form% an+ controlle+ +ru, +eli)er& %&%tem%.

/A

A<

/:

Pharmaco;inetics-- 8a%ic con%i+eration" Pharmaco7inetic mo+el%" A--lication of Pharmaco7inetic% in ne* +ru, +e)elo-ment an+ +e%i,nin, of +o%a,e form% an+ No)el +ru, +eli)er& %&%tem%.

AF

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE 2ualit& A%%urance '2.A( Semester- & %ame o! Su0DectE $etho+ of Dru, E)aluation D Clinical Re%earch 'Practical( 'S-eciali.ation?I( Su0Dect CodeE PG$P/1/P

Detailed sylla0us (Practical)

CB( 8io?anal&tical metho+ +e)elo-ment an+ it% )ali+ation. C<( Anal&%i% of 5iolo,ical flui+%. CF( Anal&%i% of +ru, in 5iolo,ical flui+%. CC( Di%%olution %tu+& of %im-le an+ mo+ifie+ relea%e %oli+ oral +o%a,e form%. /AA(
An& other rele)ant e6erci%e% 5a%e+ on theor&.

E($)%&%. @"TC@M(S--

/A/(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to learn the 5a%ic techni9ue% to

e)aluate +ru,% u%in, )ariou% animal mo+el% for +ifferent -atholo,ical con+ition%.

T($C#&%.

E($)%&%. M(T#@D@E@.Y-Facult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia

/A0(

-ro;ector.

<@@IS )(C@MM(%D(D--

/A1( /A3( /A4( /AB( /A<( /AF( /AC(

Delhi..

In+ian Pharmaco-oeia 8riti%h Pharmaco-oeia U.S. Pharmaco-oeia 8en,t L;un,,)i%t an+ 8erit Da)i% S$icro5iolo,ical Ri%7 A%%e%%ment in Pharm. Richar+ Prince" S$icro5iolo,& in Pharmaceutical $anufacturin,T. Da)i% ar*oo+ International Pu5li%hin,. A7er%" SParenteral 2ualit& ControlE Sterilit&" P&ro,en" an+ Pac7a,e Inte,rit& D. C. Garratt" The 2uantitati)e Anal&%i% of Dru,%" C8S Pu5li%her%" 0AA/" Ne* $ar7 C. Ro,,e an+ Da)i+ R Taft" SPrclinical Dru, De)elo-mentT" Dru,% an+ Donal+ $on7hou%e" Charle% Carne& an+ >imClar7" SDru, Pro+uct% For Clinical

Clean room%T. ar*oo+ International Pu5li%hin,.

Te%tin,"T 0n+ E+ition '$arcel De77er(.

//A( ///(
N.Y.

Pharm. Sci. Serie%" !ol. /40" $arcel De77er Inc." N.Y. Trial%T. 0n+ E+. ) Dru,% an+ Pharm. Sci. Serie%" !ol. /3<" 0n+ E+." $arcel De77er Inc."

//0( //1(
!ol.

Leon Shar,el" SA--lie+ 8io-harmaceutic% an+ Pharmaco7inetic%T. G. S" 8an7er D C.T. Rho+e%" U$o+ern Pharmaceutic%U" Dru,% an+ Pharm. Sci. S /0/" 3th E+." $aracel De77er Inc." N.Y. Ro*lan+ an+ To.er?Clinical Pharmaco7inetic%" conce-t% an+ a--lication. Notari.?8io-harmaceutic% an+ Pharmaco7inetic%?An intro+uction. >ohn #a,ner? Pharmaco7inetic% for Pharmaceutical %cienti%t. R ! Smith" > T Ste*art" Te6t5oo7 of 8io Pharmaceutical Anal&%i%.

//3( //4( //B( //<(

(-)(S@")C(S--

//F( //C( /0A( /0/(

***.!da.,o)@%cienceresearch@...@runnin,clinicaltrials@.. ***.!da.,o)@re,ulator&information@guidance%@ucm/00A3C.htm ***.nc5i.nlm.nih.,o)@me%h@BFAA3141 www.bionas-discovery.com ... B2500 Pre-clinical Drug Evaluatio

/00(

www.reference.md/files/D00 /mD00 !5!."tml

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE /( 2ualit& A%%urance '2.A( 0( Pharmaceutical Anal&%i% Semester- & %ame o! Su0DectE 2ualit& A%%urance Techni9ue 'G$P@GLP( 'Theor&( 'S-eciali.ation?II( Su0Dect CodeE PG$P/10
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam Hrs

(6aluatio

Marks Hrs Marks / PG$P/10 2ualit& A%%urance Techni9ue 'G$P@GLP( 3 0 ? B AB 1A /.4 <A

Ma /AA

@<F(CT&'(S-/01( To ma7e %tu+ent% familiar *ith ,oo+ manufacturin, -roce%%e% an+ ,oo+ la5orator& -ractice%.

/03( /04(

To ma7e %tu+ent% familiar *ith 9ualit& a%%urance -ro%-ecti)e To teach thi% conce-t *ith re%-ect to manufacturin, acti)itie% D relate+ area%"

mana,ement of all %tore re9uirement D relate+ matter%. P)()(C"&S&T(S--

/0B( /0<(

A %tu+ent ha% 5a%ic 7no*le+,e of G$P. A 8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent.

C@")S( @"TE&%(Sr, %o Course Content #ours

Conce-t% an+ Philo%o-h& of 2A" Role of 9ualit& au+it D 9ualit& circle in 9ualit& a%%urance 2ualit& 5& De%i,n an+ 2ualit& ri%7 mana,ement 'IC 2FD2C(. Pharmaceutical 2ualit& S&%tem 'IC 2/A(.

AB

Conce-t of Goo+ $anufacturin, Practice% Or,ani.ation D Per%onnel" re%-on%i5ilitie%" trainin," h&,iene.

A0

Premi%e%E Location" +e%i,n" Plant La&out" Con%truction" $aintenance an+ Sanitation" En)ironmental control" utilitie% an+ %er)ice% li7e ,a%" *ater" maintenance of %terile area%" an+ control of contamination.

A0

E9ui-ment%E Selection" -urcha%e %-ecification%" maintenance" clean in -lace" %terili.e in -lace" $etho+% 'TP D STP(.

A0

Ra* $aterial%E Purcha%e %-ecification%" maintenance of Store%" %election of !en+or%" control on ra* material% an+ fini%he+ +o%a,e form%.

A3

$anufacture of D control on +o%a,e form%E manufacturin, +ocument%" ma%ter formula" 5atch formula recor+%" %tan+ar+ o-eratin, -roce+ure%" 9ualit& au+it% of manufacturin, -roce%%e% an+ facilitie%.

A3

In Proce%% 9ualit& control% on )ariou% +o%a,e form%E Sterile an+ non %terile" %tan+ar+ o-eratin, -roce+ure% for )ariou% o-eration% li7e cleanin," fillin," +r&in," com-re%%ion" coatin," +i%infection%" %terili.ation" mem5rane filtration etc.

AF

Pac7a,in, an+ la5elin, control" Line clearance" reconciliation of la5el%" carton% an+ other -ac7a,in, material%.

A0

2ualit& control La5orator&E Re%-on%i5ilitie%. Routine control% in%trument%" rea,ent%" %am-lin, -lan%" %tan+ar+ te%t Proce+ure%" -rotocol%" +ata ,eneration an+ %tora,e" 9ualit& control +ocument%" retention %am-le%" recor+%" au+it% of 9ualit& control facilitie%.

AF

/:

Fini%he+ -ro+uct relea%e" 9ualit& re)ie*" 9ualit& au+it% an+ 5atch relea%e +ocument%.

A0

//

#arehou%in," +e%i,n" con%truction" maintenance an+ %anitation: ,oo+ *arehou%in, -ractice" material% an+ mana,ement.

A0

/2

Di%tri5ution an+ +i%tri5ution recor+%" han+lin, of returne+ ,oo+%" reco)ere+

A1

material% an+ re-roce%%in,. /1 Com-laint% an+ recall%" e)aluation of com-laint%" recall -roce+ure%" relate+ recor+% an+ +ocument%. /4 /3 /4 /5 /7 #a%te +i%-o%al" %cra- +i%-o%al -roce+ure% an+ recor+%. Goo+ La5orator& Practice%. # O certification. Te%tin, of Pac7a,in, material%. S-ecification% for material%" interme+iate% an+ fini%he+ -ro+uct. Total A0 A4 A0 A0 A0 BA A0

E($)%&%. @"TC@M(S--

/0F(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to %tu+& *orl+*i+e acce-te+

manufacturin, -roce%%e%" ,oo+ la5orator& -ractice% an+ 5a%ic of 9ualit& a%%urance.

T($C#&%.

E($)%&%. M(T#@D@E@.Y-Facult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia

/0C(

-ro;ector.

<@@IS )(C@MM(%D(D--

/1A( /1/( /10( Sci. /11( /13( /14(

Si+ne& . #illi," UGoo+ $anufacturin, Practice% for Pharmaceutical%U" 8olton" UPharmaceutical Stati%tic%E Practical D Clinical A--lication%U" G. S" 8an7er D C.T. Rho+e%" U$o+ern Pharmaceutic%U" Dru,% an+ Pharm. Serie%"!ol. /0/" 3th E+." $aracel De77er Inc." N.Y. P. P .Sharma S o* to -ractice G$P%T" 1r+ e+ition !an+ana Pu5lication. P. P. Sharma S o* to -ractice GLPT !an+ana Pu5lication. S. #ein5er," SGoo+ La5orator& Practice Re,ulationT Dru,% an+ Pharm.

Dru,% an+ Pharm. Sci. Serie%" !ol. /AC" $arcel De77er Inc." N.Y. Dru,% an+ S Pharm. Sci. Serie%" !ol. /14" 3th E+." $arcel De77er Inc." N.Y.

Sci. Serie%"!ol. /03" 0n+ E+." $aracel De77er Inc." N.Y. /1B( /1<( /1F( /1C( /3A( /3/( In+ia. /30( /31( Goo+ la5orator& Practice" >ur, Seiler" S-rin,er Ne* Yor7. Goo+ La5orator& Practice an+ Re,ulator& I%%ue%" P. !. $ohanan" # OJ% SDru,T 8ulletin%. Remin,ton% SPharmaceutical Science%T. G$P -ractice% for -harmaceutical?>ame% S*ar5ric7. 2ualit& A%%urance of Pharmaceutical%" !olume ID II" 'A Com-en+ium Pharmaceutical 2ualit& A%%urance" $A Pot+ar" Nirali Pra7a%han" Pune. 2ualit& A%%urance Gui+e 5& Or,ani.ation of Pharmaceutical -ro+ucer% of

,ui+eline% D Relate+ $aterial%(" Pharma5oo7 S&n+icate" # O" Gene)a.

E+ucational 5oo7 centre" $um5ai

(-)(S@")C(S--

/33( /34( /3B( /3<(

***.ich.or,@-ro+uct%@,ui+eline%@Huality.html ***.*erum.+e@en@,5@file+o*n@file+o*n+5.;%-V...@t6t@...A.. indiagl#.gov.in/ ***.f+a.,o)@+ru,%@...@manu!acturing@ucm/BC/A4.htm

www.w"o.int/medicines/areas/$uality%safety/$uality.../#roduction/

C. U. S A

UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE Pharmaceutical Anal&%i% Semester- & %ame o! Su0DectE A+)ance Anal&tical Techni9ue% 'Theor&(

'S-eciali.ation?I( Su0Dect CodeE PG$P/3/

Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam Mar;s #rs / PG$P/3/ A+)ance Anal&tical Techni9ue% 3 0 B /0 /0 1A /.4 University Exam Mar;s <A #rs

(6aluation Sch

Sessi Exa Mar;s /A A 1A

@<F(CT&'(S- /3F( To ma7e %tu+ent% familiar *ith the -rinci-le% of a+)ance anal&tical techni9ue% an+ their a--lication% in -harmac& *ith %ome recent +e)elo-ment%.

P)()(C"&S&T(S- -

/3C(

8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent

C@")S( @"TE&%(-Sr, %o / Course Contents

/1 /1

#ours 9

C Nuclear $a,netic Re%onance '/1C?N$R( Natural a5un+ance of C" re%olution an+ multi-licit& FT mo+e" RF mo+e" NOE" Cro%%

-olari.ation" u%e% of -roton cou-le+" +ecou-le+ an+ off re%onance +ecou-lin, techni9ue%" +euterium %u5%titution" chemical e9ui)alence in -ea7 a%%i,nment" chemical %hift" Effect of %u5%titution on chemical %hift%. 2 Princi-le" in%trumentation" a--lication% an+ a+)ance +e)elo-ment of follo*in, %-ectro%co-ic metho+%. /2

a, Raman %-ectro%co-&

0, Electron %-in re%onance %-ectro%co-& c, Atomic a5%or-tion %-ectro%co-& an+ metal e%timation 5& AAS
1 A +etaile+ %tu+& of the -rinci-le%" in%trumentation% an+ a--lication% in +ru, anal&%i% ofE GC?$S" LC?$S *ith reference to 9uantification of +ru,% in 5iolo,ical %am-le%. 4 Princi-le" in%trumentation" a--lication% an+ a+)ance +e)elo-ment of follo*in, %e-aration techni9ue%. 3 /:

a, Ca-illar& electro-hore%i% 0, Counter current chromato,ra-h&

3 Princi-le" *or7in, an+ +ifferent t&-e% of LASER an+ Particle %i.in, 5& la%er +iffraction e9ui-ment 4 A+)ance +e)elo-ment in i,h -erformance li9ui+ chromato,ra-h& li7e UPLC" Nano LC" Column %*itchin," Ra-i+ re%olution LC" etc. 5 Princi-le" in%trumentation an+ a--lication of follo*in, anal&tical techni9ue% *ith a--lication of the %ame in )ariou% +ru, an+ +ru, formulation a% -er IP 9 1 4

A. Fluore%cence %-ectro%co-& 8. Non a9ueou% titration% C. Potentiometric titration%

7 9 /: Automate+ anal&%i% $icro5iolo,ical limit te%t Sterilit& te%tin, Total 2 1 1 4:

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE Pharmaceutical Anal&%i% Semester- & %ame o! Su0DectE A+)ance Anal&tical Techni9ue% 'Practical( 'S-eciali.ation?I( Su0Dect CodeE PG$P/3/P
Detail sylla0us (Practical)

/4A(

Anal&%i% of +ifferent formulation of +ru,% u%in, flourimetr&" non a9ueou%

titration" -otentiometr& a% -er IP /4/( /40( /41( /43( /44( Sterilit& te%tin, of +ifferent %terile mar7ete+ -re-aration% $icro5iolo,ical limit te%t a% -er IP PLC anal&%i% of API an+ Formulation% a% -er IP Electro-hore%i% of Amino aci+ an+ %erum -rotein% 2C te%t of ta5let% a% -er IP

E($)%&%. @"TC@M(S--

/4B(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to un+er%tan+ the fun+amental

conce-t of mo+ern anal&tical techni9ue%" *hich i% im-ortant for 9ualitati)e a% *ell a% 9uantitati)e anal&%i% of +ru, %u5%tance% an+ +ru, -ro+uct. T($C#&%. E($)%&%. M(T#@D@E@.Y-Lecture% u%in, 5lac7 5oar+ an+ Po*er -oint Pre%entation" !i%ual Gra-hic%"

/4<(

Practical +emon%tration% an+ Practical *or7in,.

<@@IS )(C@MM(%D(D--

/4F(

Pharmaceutical Anal&%i% N $o+ern $etho+% N Part A" Part 8" >ame% #. $un%on N

0AA/. /4C( /BA( A te6t 5oo7 of Pharmaceutical anal&%i% 5& L.A.Conner% '>ohn #ile&( Lena Ohanne%ian an+ Anthon& >. Streeter" an+ 8oo7 of Pharmaceutical

Anal&%i%" /B/( /B0( Pharm Sci. %erie%" !ol. //<" $aarcel De77er Inc." N.Y Satin+er Ahu;a an+ $ichael Don," an+ 5oo7 of -harmaceutical anal&%i% 5&

PLC" %e-aration %cience an+ technolo,&" !olume B" El%e)ier. /B1( Pa)ia" Lam-man an+ 7ri." Intro+uction to %-ectro%co-&" thir+ e+ition" Thom%on

learnin,. /B3( /B4( /BB( /B<( /BF( Pharmaceutical Anal&%i% 5& Ohanna%on. Chemical Anal&%i% 5& Settle. Chemical Anal&%i% N $o+ern In%trumentation metho+% an+ techni9ue% 5& #ile&. In%trumental metho+% of anal&%i% 5& #illar+ Dean D $errit. an+ 5oo7 of In%trumental techni9ue% for anal&tical chemi%tr& e+ite+ 5& Fran7

%ettle -u5. 8& Prentice all Inc.

(-)(S@")C(S--

/BC( /<A(

Re)ie* article% from El%e)ier ;ournal% Re)ie* article% from ***.%cience+irect.com

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmacolo,& D To6icolo,& DisciplineE Pharmacolo,& Semester- & %ame o! Su0DectE $olecular Pharmacolo,& 'Theor&( 'S-eciali.ation?I( Su0Dect CodeE PG$P/4/
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam Mar;s / PG$P/4/ $olecular Pharmacolo,& 3 0 B /0 /0 1A #rs /.4 University Exam Mar;s <A #rs

(6aluati

M /AA

@<F(CT&'(S-. To im-art a+)ance 7no*le+,e a5out rece-tor mechani%m of +ru, action. To train the %tu+ent in 'a( rece-tor mechani%m% '5( Pharmacolo,ical action% of 5io acti)e molecule%. To ,i)e a+)ance+ 7no*le+,e in the%e area%

P)()(C"&S&T(S- 8a%ic fun+amental 7no*le+,e a5out +ru, action D 5io?molecule%. 8. Pharm. +e,ree from an& in%titution a--ro)e+ 5& AICTE or it% e9ui)alent

C@")S( @"TE&%(-Sr, %o 1 Topic Molecular mechanism o! drug actionRece-tor %tructure" Si,nal tran%+uction mechani%m" Termination of rece-tor acti)it&" Rece-tor malfunction" Ra+io li,an+ 5in+in, %tu+ie%" Dru, rece-tor interaction" Do%e re%-on%e relation%hi-" Potenc&"Efficac& an+ Anta,oni%m% 2 Pharmacology o! receptorsCla%%ification" cellular %i,nalin, %&%tem%" a%%ociate+ +i%ea%e% an+ a+)ance% in -harmacolo,& of the follo*in, rece-tor t&-e% 1 E6citator& amino aci+ rece-tor" 2 Do-amine Rece-tor" 3 N$DA Rece-tor" 4 GA8A an+ 8en.o+ia.e-ine Rece-tor" 5 Puriner,ic Rece-tor" 6 Gl&cine Rece-tor" 7 Canna5inoi+% Rece-tor" 8 O-ioi+ Rece-tor%" 3 9 Imi+a.oline Rece-tor Pharmacology o! Channels1 So+ium channel" 2 Potta%ium channel" 3 Chlori+e channel an+ 4 4 Calcium channel% (ndogenous <ioacti6e MoleculesPh&%iolo,&" Pharmacolo,& an+ Thera-eutic -otential of 1 Nitric O6i+e 'EDRF( < B /4 #rs /A

2 En+othelin 3 Pho%-ho+ie%tra%e En.&me an+ Protein Lina%e C 4 En+or-hin% 5 5 Neurotro-in% Pharmacology o! %europeptides8iolo,ical function%" -harmacolo,ical im-lication%" their rece-tor% %&%tem% an+ thera-eutic -otential% of 1 Neuro-e-ti+e Y 2 Cholec&%to7inin 3 Tach&7inin% 'Su5%tance P@ Neuro7inin( 4 $elanocortin% ' Al-ha $S ( 5 Cortcotro-hin relea%in, factor 6 Ar,inine )a%o-re%%in 7 Cocaine NAm-hetamine Re,ulator& Tran%cri-t ' CART( 6 8 Calcitonin ,ene?relate+ -e-ti+e 'CGRP( Cyto;ines Chemo;inesCla%%ification" -h&%iolo,&" -harmacolo,&" -atholo,ical" an+ thera-eutic im-lication% of 1 Tumor necro%i% factor 'TNF?W(" 2 Interferon%" 3 Interlu7ine% 'IL(" 4 A+he%ion molecule%" 5 Gro*th factor% 4 /0

$poptosis and %ecrosis$olecular 5iolo,&" -h&%iolo,ical an+ -harmacolo,ical im-lication% an+ thera-eutic -otential% of a-o-to%i%. Total

BA

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmacolo,& D To6icolo,& DisciplineE Pharmacolo,& Semester- & %ame o! Su0DectE $olecular Pharmacolo,& 'Practical( 'S-eciali.ation?I( Su0Dect CodeE PG$P/4/P
Detail Sylla0us (Practical)

/</( /<0( /<1( /<3( /<4(

Intro+uction to e6-erimental animal%" ethic% in -harmacolo,ical e6-eriment%" $etho+% for euthana%ia" ane%the%ia" +o%in, an+ 5loo+ collection 5& )ariou% To %tu+& effect of )ariou% +ru,% on a+rener,ic" choliner,ic" hi%taminer,ic an+ To %tu+& the effect of )ariou% channel 5loc7er% on re%-on%e% of )ariou% a,oni%t% To %tu+& the effect of +ru,% on )ariou% car+io)a%cular -arameter% in animal%E

CPCSEA Gui+eline% techni9ue% %erotoner,ic rece-tor% u%in, )ariou% i%olate+ ti%%ue. on i%olate+ ti%%ue. ECG" ELG an+ 5loo+ -re%%ure.

E($)%&%. @"TC@M(S- At the en+ of the cour%e" the %tu+ent *ill 5e a5le to learn the molecular 5a%i% of -harmacolo,&. It *oul+ 5e hel-ful in fin+in, out molecular mechani%m 5ehin+ ne* +i%co)ere+ +ru,.

T($C#&%.

E($)%&%. M(T#@D@E@.Y--

Facult& mem5er% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia -ro;ector.

<@@IS )(C@MM(%D(D--

/<B( /<<( /<F( /<C( /FA( /F/( /F0( /F1( /F3( /F4( /FB( /F<( /FF(
$e+ical.

ar+man >. G." Lim5ir+ L. E. 0AA/. SGoo+man an+ GilmanJ% The Da)i+ E. Golan" SPrinci-le% of Pharmacolo,&?The Patho-h&%iolo,ic 5a%i% of . P. Ran, an+ $. $. Dale" SPharmacolo,&T 4th E+. Churchill Li)in,%tone. 8. G. Lat.un," S8a%ic an+ Clinical Pharmacolo,&T Cth E+. $cGra*? ill Annual Re)ie*% of Pharmacolo,& %erie%. ar)e& R. A" Cham-e P. C." SPharmacolo,&?Li--incottJ% illu%trate+ Re)ie*%T >ournal Tren+% in Pharmacolo,ical %cience%. Ganon, #illiam% F." SRe)ie* of me+ical Ph&%iolo,&T Paul L. $un%on" SPrinci-le% of Pharmacolo,&. >ame% Cro%%lan+" SLe*i%J% Pharmacolo,&T Churchil Li)in,%tone. $. N. Gho%h" SFun+amental% of E6-erimental Pharmacolo,&T 3th E+. ilton S. L. Lul7arni" S an+5oo7 of E6-erimental Pharmacolo,&T R. L. Go&al" SPractical% in Pharmacolo,&T 8.S. Shah Pra7a%han

Pharmacolo,ical 8a%i% of Thera-eutic%T /Ath E+.$cGra*? ill Profe%%ional. +ru, thera-&T 0n+ E+. Li--incott #illiam% D #il7in%.

3th E+. Li--incott #illiam% D #il7in%.

(-)(S@")C(S--

/FC( /CA( /C/( /C0( /C1( /C3( /C4( /CB(

htt-E@@***.nc5i.nlm.nih.,o)@-mc@article%@P$C0BC<BF/@ htt-E@@***.r-i.e+u@+e-t@5c5-@mol5iochem@$8#e5@m5/@-art0@%i,nal%.htm htt-E@@circre%.aha;ournal%.or,@content@/AA@1@1AC.full htt-E@@***.nc5i.nlm.nih.,o)@-mc@article%@P$C1/A3B/F@ htt-E@@***.nc5i.nlm.nih.,o)@-u5me+@//40AC/B htt-E@@,ene%+e).c%hl-.or,@content@/3@01@0C/C.full htt-E@@***.nc5i.nlm.nih.,o)@-mc@article%@P$C/4<4/<1@ htt-E@@***.nc5i.nlm.nih.,o)@-u5me+@//BA0AA/

C. U. S A UNI!ERSITY #AD #ANCITY

FacultyE ? Pharmaceutical Science% DepartmentE Pharmacolo,& D To6icolo,& DisciplineE Pharmacolo,& Semester- & %ame o! Su0DectE A+)ance+ Pharmacolo,&?I 'Theor&( 'S-eciali.ation?II( Su0Dect CodeE PG$P/40
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam Mar;s / PG$P/40 A+)ance+ Pharmacolo,&?I 3 0 ? B AB 1A #rs /.4 University Exam Mar;s <A #rs

(6aluation

Se

Ma /AA

@<F(CT&'(S- To im-act 7no*le+,e a5out late%t +ru,% a)aila5le for thera-eutic%. To 5rain the %tu+ent in ne* +ru, thera-& )ariou% +i%ea%e% *ith re%-ect to $OA +o%a,e" a+)er%e effect%.

P)()(C"&S&T(S- Lno*le+,e a5out the 5a%ic% of -harmacolo,&. 8. Pharm. +e,ree from an& in%titution a--ro)e+ 5& AICTE or it% e9ui)alent

C@")S( @"TE&%(-Sr, %o Course Content #rs

The s /&ect sho ld ,i0e e$)hasis on recent trends and ad0ances in )har$acolo,# o" "ollo'in,s1 1 2 $utocoids- i%tamine" Serotonin" Pro%ta,lan+in%" Leu7otriene%" Throm5o6ane" PAF" An,ioten%ine" Linin%" Su5%tance P" Cholec&%to7inin P%S PharmacologyS&m-athomimetic%" S&m-athol&tic%" Para%&m-athomimetic%" Para%&m-athol&tic%" Gan,lion 8loc7er% an+ Stimulator" Neuromu%cular 8loc7er% an+ Acti)ator%" General an+ Local Ane%thetic% Chemotherapy- Intro+uction to Infectiou% Di%ea%e%" Princi-le% of Chemothera-&" $ana,ement of Infectiou% Di%ea%e%" Penicillin%" Ce-halo%-orin%" Sul-honami+e%" $acroli+e%" Amino,l&co%i+e%" 2uinolone%" Tetrac&cline" Chloram-hanicol" Chemothera-& of Tu5erculo%i% an+ Le-ro%&" Antifun,al a,ent%" Anti?)iral a,ent%" Anti?-roto.oal a,ent%" Anthelmintic%" Chemothera-& of Se6uall& Tran%mitte+ Di%ea%e 'STD(" Recent a+)ance% in Cancer &mmunopharmacologyimmuno%u--re%%ant% Intro+uction to Immunit&" Immuno%timulant%" /A /A

0A

4 5 6

B < <

Stem Cell Therapeutics- 8iolo,& of %tem cell% an+ their -otential% in )ariou% +i%ea%e% .ene Therapy- Conce-t of ,ene thera-& an+ recent +e)elo-ment in the treatment of )ariou% here+itar& +i%ea%e%. Total

BA

E($)%&%. @"TC@M(S--

/C<(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to un+er%tan+ the Pharmacolo,&"

Patho-h&%iolo,& an+ Thera-eutic 5a%i% of +ru, treatment.

T($C#&%.

E($)%&%. M(T#@D@E@.Y--

Facult& mem5er% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia -ro;ector.

<@@IS )(C@MM(%D(D--

/CF(

ar+man >. G." Lim5ir+ L. E. 0AA/. SGoo+man an+ GilmanJ% The

Pharmacolo,ical 8a%i% of Thera-eutic%T /Ath E+.$cGra*? ill Profe%%ional.

/CC( 0AA( 0A/( 0A0( 0A1( 0A3( 0A4( 0AB( 0A<(

Da)i+ E. Golan" SPrinci-le% of Pharmacolo,&?The Patho-h&%iolo,ic 5a%i% of . P. Ran, an+ $. $. Dale" SPharmacolo,&T 4th E+. Churchill Li)in,%tone. Paul L. $un%on" SPrinci-le% of Pharmacolo,&. >ame% Cro%%lan+" SLe*i%J% Pharmacolo,&T Churchil Li)in,%tone. Po%e-h T. Di-iro" SPharmacothera-&?A -atho-h&%iolo,ical a--roachT Crai," Charle% R." S$o+ern Pharmacolo,& *ith clinical a--lication%T .L. Sharma" SPrinci-le% of Pharmacolo,&T L.D. Tri-athi" S E%%ential% of $e+ical Pharmacolo,&T $&ce7 $ar& >." SLi--ncottJ% Illu%trate+ Re)ie* of Pharmacolo,&T

+ru, thera-&T 0n+ E+. Li--incott #illiam% D #il7in%.

(-)(S@")C(S--

0AF( 0AC( 0/A( 0//( 0/0(

htt-E@@***.emcell.com@en@li%tXofX+i%ea%e%@+ia5ete%Xtreatment.htm htt-E@@***.emcell.com@en@li%tXofX+i%ea%e%@-ar7in%onXtreatment.htm htt-E@@r%t5.ro&al%ociet&-u5li%hin,.or,@content@1B4@/41<@/44.full htt-E@@***.nc5i.nlm.nih.,o)@-u5me+@/BCFF/A0 htt-E@@***.n+%u.e+u@-u5*e5@Ymcclean@-l%c31/@%tu+ent%@,uo;un.htm

C " S#$# "%&'()S&TY

*$D#*$% C&TY

%ame o! Faculty- Pharmaceutical Science Proposed Sylla0i !or Master in Pharmacy Semester-&& %ame o! Discipline0/1( Pharmaceutics 0/3( 0/4( 0/B( 0/<(

Pharmaceutical Technology Cuality $ssurance Pharmaceutical $nalysis Pharmacology

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE All Di%ci-line Semester- && %ame o! Su0DectE Dru, Re,ulator& A%-ect% D IPR 'Theor&( Su0Dect CodeE PG$P0A/
T($C#&%. ('$E"$T&@% SC#(M(--

Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam

(6aluation

Se

Marks Hrs Marks Hrs / PG$P0A/ Dru, Re,ulator& A%-ect% D IPR 3 ? ? 3 A3 1A /.4 <A

Mar /AA

@<F(CT&'(S0/F( To e6-lore the re,ulator& -ro)i%ion% *ith re%-ect to clinical trial%" In)e%ti,ational Ne* Dru, A--lication" Ne* Dru, A--lication" ANDA" mar7et authori.ation of me+icine%" in%-ection of Pharmaceutical manufacture% an+ -ro+uct re,i%tration. 0/C( To e6-lore -ractical a%-ect% re-eate+ to -atentin, Stu+ent% learnin,

P)(-)(C"&S&T(00A( A cour%e at UG le)el re,ar+in, re,ulator& a%-ect%" la* ,o)ernin,

Pharmac& -rofe%%ion. 00/( A 8. Pharm. De,ree from an& in%titution a--ro)e+ 5& AICTE or it%

e9ui)alent. C@")S( @"TE&%(Sr , % o 0 1 Dru, Re,ulator& A%-ect% 'In+ia( In+ian +ru, re,ulator& authoritie%" Central an+ State re,ulator& 5o+ie% 'FDA(" Dru,% an+ Co%metic% Act an+ Rule% *ith late%t Amen+ment%." Ne* Dru,% N Im-ortation" Re,i%tration" +e)elo-ment" clinical trial%" 8E NOC D 8.E. %tu+ie%" !ariou% licen%e% N Te%t lic." Im-ort /: C@")S( C@%T(%TS #)S

lic. for te%tin, of +ru,% an+ APIJ%" $f,." Contract an+ Loan licen%e 0 2 manufacturin,. $ppro6al o! %e+ drugsIn)e%ti,ational Ne* Dru, 'IND( %u5mi%%ion" format D content of IND" content of In)e%ti,ator 8rochure" ,eneral con%i+eration of Ne* Dru, A--ro)al 'NDA(" %-ecific re9uirement%" content D format of NDA" 0 manufacturin, control re9uirement of NDA, Drug )egulatory $spects (&nternational highly regulated mar;ets) 0. CTD Format% of +o%%ier%" E?%u5mi%%ion" US D$F ')ariou% t&-e%(" IIG Limit%" Ar-han Dru,%" )anilla ANDAJ%" e6hi5it@-i)otal 5atche%" )ali+ation 5atche%" )ariou% ,ui+ance i%%ue+ 5& CDER" OGD" Oran,e 8oo7 'an+ -atent%(" RLD 'reference li%te+ +ru,( for 8E %tu+ie% an+ the norm% for US %u5mi%%ion" 5ioe9ui)alence an+ +i%%olution recommen+ation%" -ac7a,in," %ta5ilit& %tu+ie% an+ the -ro+uct information leaflet" US FDA in%-ection 'au+it%(" -re?a--ro)al in%-ection% an+ a--ro)al%. 1. Euro-ean Union Re9uirement% 3. All the a%-ect% for Euro-ean re,i%tration of formulation% for ,eneric +ru,% %ale in the Euro-ean mar7et% un+er EU. E$EA ,ui+eline% on )ariou% a%-ect% a% a5o)e 'C /(. 4. A 5rief intro+uction to the ,ui+eline% for >a-an" Au%tralia" South Africa" Re%t of the #orl+ 'RO#( an+ South D Latin American countrie%. 4, G$P au+it%" role of 9ualit& a%%urance" -ro+uct a--ro)al% an+ %u--lie%. 0 Intro+uction to IPR D Patent% N De)elo-ment of IP la* in In+ia" IPR re,ime" 4 intro+uction to IP la*% in In+ia" Intro+uction" -atent le,i%lation" In+ian Patent% Act /C<A an+ amen+ment%" -roce+ure for -atent a--lication" ,rant an+ o--o%ition -rocee+in,%" -atent licen%in," -atent infrin,ement -rocee+in,%" IPA8 N role an+ function% 'IP A--ellate 8oar+(" In+ian IP ca%e la*%. American D Euro-ean -atent %&%tem N Re9uirement% for -atentin," utilit&" no)elt& non?o5)iou%ne%%" -atent %-ecification D claim%" -atent infrin,ement an+ +octrine of e9ui)alent%" fe+eral circuit an+ -atent %&%tem in Euro-e. /: /3 /:

3 /. US Re9uirement% N 'for Generic Dru,% e%-eciall& formulation%(.

Patent %earch" -atent anal&%i% D -atent +raftin,. Allie+ Patent% Relate+ I%%ue%E 0 5 E6-loitation of -atent" a5u%e of /: -atent%" com-ul%or& licen%in," infrin,ement anal&%i%" +ru,?-atent lin7a,e. International treatie% an+ con)ention% on IPR ? Pari% con)ention" PCT N an intro+uction" PCT a--lication D ,eneral rule%" #TO @ GATT %&%tem D Uru,ua& TRIPS" #IPO. $e+icare 0 6 $o+erni.ation atch #a6man Act an+ amen+ment%" FDA Act" 0AA1. Intro+uction to ,eo,ra-hical :3

in+ication@tra+emar7@co-&ri,htE filin, -roce+ure%. IPR an+ Pharmaceutical Re%earchE 8enefit% of IPR% to im-ro)e the 9ualit& of re%earch *or7 Strate,ie% for

a)oi+in, re%earch +u-lication%" infrin,ement% Total E($)%&%. @"TC@M(S000(

4:

To ,et familiar *ith re,ulator& a%-ect% relate+ to Re%earch D

De)elo-ment a% *ell a% manufacturin, an+ mar7etin, of Pharmaceutical Pro+uct% T($C#&%. 001( E($)%&%. M(T#@D@E@.YThe cour%e em-lo&% lecture% an+ cla%% +i%cu%%ion%. It al%o inclu+e%

-re%entation 5& %tu+ent% on a %-ecific to-ic a%%i,ne+ to them 5& the facult&. <@@IS )(C@MM(%D(D-/. G$P% 5& $ehra 0. The Dru,% an+ Co%metic Act" /C3A 5& !i;a& $alli7 1. o* to Practice G$P 5& P.P.Sharma.

3. E$EA Pu5lication% an+ Gui+ance. 4. Oran,e 8oo7" IC ,ui+eline%" In+ian Patent% Act B. Countr& %-ecific Re,ulator& Gui+eline% 'a)aila5le from internet( <. Go)t. Pu5lication% on i%%ue% affectin, %ale%" +i%tri5ution" manufacturin," e6ci%e" etc. F. >. D. Nall&" SGoo+ manufacturin, Practice for Pharmaceutical%T Informa ealthcare.

C. I. Lanfer D L. Shar,el" SGeneric Pro+uct De)elo-ment 8E i%%ue+T Informa ealthcare. /A. Pharmaceutical Pro+uct De). I!I!C 5& $urth&" Sun7ara an+ Da)i+ //. USPTO an+ #IPO Gui+eline%. /0. Gnarino Richar+ A" Ne* Dru, A--ro)al Proce%%" 1 r+ E+." $arcel De77er Inc. (-)(S@")C(S003( 004( 00B( 00<( ***.mohf*.nic.in ***.u%f+a.,o) ***.mhra.,o).u7 ***.ich.or,@cache@com-o@1B1?0<0?/.html

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE All Di%ci-line Semester- && %ame o! Su0DectE Re%earch $etho+olo,& 'Theor&( Su0Dect CodeE PG$P0A0
T($C#&%. ('$E"$T&@% SC#(M(-Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam Hrs

(6aluatio

Marks Hrs Marks / PG$P0A0 Re%earch $etho+olo,& 3 ? ? 3 A3 1A /.4 <A

Ma /AA

@<F(CT&'(S00F( To ma7e %tu+ent% familiar *ith )ariou% e%ta5li%he+ metho+% u%e+ in -harmaceutical re%earch. 00C( 01A( To familiar %tu+ent *ith ho* to *rite the%i% an+ Re%earch -u5lication To a*are %tu+ent% a5out fun+ re%ource% for re%earch *or7

P)()(C"&S&T(S-01/( 8a%ic 7no*le+,e in 8io -harmaceutic%" -harmaco7inetic% D 5a%ic% of

+ru, +eli)er& in 5o+&. 010( 011( Fun+amental un+er%tan+in, of 5io%tati%tic% 8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent.

Detailed Sylla0us (Theory) Sr. No 1 <asics o! )esearch Definition" o5;ecti)e%" moti)ation" t&-e% of re%earch 'E+ucational" Clinical" E6-erimental" an+ i%torical +e%cri-ti)e" 8a%ic a--lie+ an+ Patent oriente+ Re%earch( an+ a--roache%E +e%cri-ti)e re%earch" 2 conce-tual" theoretical" a--lie+ an+ e6-erimental. Formation o! )esearch Proposal A. Re%earch Proce%%E To +etermine *hat t&-e of re%earch to 5e +one" Plan of re%earch *or7. 8. Selection of re%earch area" -rioriti.ation of re%earch. C. Literature re)ie*E im-ortance an+ metho+%" %ource% 'U%e of Li5rar&" 5oo7% an+ ;ournal%?$e+line?Internet" Patent" article% ( D. O5;ecti)e% an+ %co-e of *or7" +e)elo-in, re%earch -lan an+ %che+uleE Sche+ulin, con%traint%" %te-%" -ro5lem% in %che+ulin," limitation%. AB A4 C@")S( C@%T(%TS #rs

3 4

&ndustrial-institution interaction? In+u%trial -ro;ect%" their" fea%i5ilit& re-ort%. Interaction *ith in+u%trie%. (thical issues in research i%torical -er%-ecti)e%" General -rinci-le% on ethical con%i+eration in)ol)in, human -artici-ation" General ethical e)aluation of +ru,%@ +e)ice@ +ia,no%tic%@)accine%@ her5al reme+ie%. Statement of %-ecific -rinci-le% for human ,enetic% an+ ,enomic re%earch. International Conference on armoni.ation. Goo+ clinical -ractice% norm%" Ethical -rinci-le% relate+ to animal e6-eriment%. Cost analysis Funding 8 Scholarship Co%t anal&%i% of the -ro;ect N co%t incurre+ on ra* material%? Proce+ure" in%trumentation% an+ clinical trial%. A,encie% 'international a,encie%" Go)ernment an+ -ri)ate 5o+ie%.( fun+in, re%earch in -harmaceutical %cience%" Scholar%hi-" t&-e% of %cholar%hi-% in e+ucation. DocumentationA. S o*T of +ocumentation 8. Techni9ue% of +ocumentation C. Im-ortance of +ocumentation D. U%e of com-uter -ac7a,e% in +ocumentation. )esearch Deli6era0les a( 'arious Forms o! Pu0licationE The%i%" -a-er" re%earch -ro-o%al. 5( )esearch )eport Paper +riting Thesis *riting8/.Title NTitle of -ro;ect *ith author% name 0. A5%tract? Statement of the -ro5lem" 8ac7,roun+ li%t in 5rief an+ Pur-o%e an+ Sco-e. 1. Le& #or+%. 3. $etho+olo,&?%u5;ect" a--aratu%" in%trumentation D -roce+ure. 4. Re%ult%? ta5le%" ,ra-h%" fi,ure% D %tati%tical -re%entation B. Di%cu%%ion %u--ort or non %u--ort of h&-othe%i%" -ractical D theoretical Im-lication% <. Conclu%ion F. Ac7no*le+,ement%.

A3 /0

A<

A1

0A

C. Reference% /A. Errata //. Im-ortance of S-ell chec7 for entire -ro;ect /0. U%e% of footnote% c( Presentation- PosterA proposalA and oral paper presentation, Im-ortance" t&-e% +ifferent %7ill%" containe+" format of mo+el" intro+uction" Po%ter" Ge%ture%" e&e contact" facial" e6-re%%ion%" %ta,e" fri,ht" )olume? -itch" %-ee+" -au%e D lan,ua,e" !i%ual ai+% D %eatin," 2ue%tionnaire. 8 Plagiarism I%%ue% relate+ to -la,iari%m" co-&ri,ht la*%" ac7no*le+,in, the %ource%" format for manu%cri-t *ritin," +ocumentation" or,ani.ation of reference material" 8i5lio,ra-h&" en+ note. A1

E($)%&%. @"TC@M(S013( The %tu+ent *ill 5e a5le to un+er%tan+ the hierarch& of continue re%earch

5& -ro-er fun+amental metho+olo,& an+ 7no*ho* a5out re%earch -u5lication an+ re%ource% for re%earch ,rant. T($C#&%. 014( E($)%&%. M(T#@D@E@.YFacult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+

multime+ia -ro;ector 01B( The cour%e em-lo&% lecture% an+ cla%% +i%cu%%ion%. It al%o inclu+e%

-re%entation 5& %tu+ent% on a %-ecific to-ic a%%i,ne+ to them 5& the facult&. )(C@MM@%D(D <@@IS01<( C.R. Lothari" 0AA3. SRe%earch $etho+olo,&T. 0n+ E+. Ne* A,e International '-( Limite+" Pu5li%her%. 01F( >.#. 8e%t an+ >.!. Lahn" 0AAB. SRe%earch in E+ucationT. /Ath E+. P I

-u5lication. 01C( >.R. Fraen7el" N.E. #allen" 0AAF. S o* to De%i,n an+ E)aluate Re%earch in E+ucationT" <th E+. 8o%tonE $cGra*? ill. 03A( G. 8or+a,e" 8. Da*%on" 0AA1. E6-erimental %tu+& +e%i,n an+ ,rant *ritin, in ei,ht %te-% an+ 0F 9ue%tion%. $e+ical E+ucation" 1<'3(E 1<B?1F4. 03/( 030( 031( 033( 034( 03B( 03<( 03F( 03C( 04A( 04/( $anual for e)aluation of in+u%trial -ro;ect%?Unite+ Nation%. $anual for the -re-aration of in+u%trial fea%i5ilit& %tu+ie%. Protection of in+u%trial Pro-ert& ri,ht%? P. Da% D Go7ul Da%. Documentation N Gene%i% D De)elo-ment 1<C0. The%i% -ro;ect% in Science D En,ineerin, N Richar+ $. Da)i%. The%i% D A%%i,nment N >onathan An+er%on. #ritin, a technical -a-er? Donal+ $en.el. Effecti)e 8u%ine%% Re-ort #ritin, NLelan+ 8ro*n. S-ellin, for the million%? E+na Furme%%. Pre-aration for -u5lication N Lin, E+*ar+ o%-ital Fun+ for Lon+on. Information Technolo,& N The in+u %-ea7%. allon? In+ian Societ& for In%titute

040( Pre%entation %7ill% ? $ichael e+ucation. 041(

Practical Intro+uction of co-&ri,ht. ? Ga)in $cfarlane.

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutic% D Pharmaceutical Technolo,& DisciplineE /( Pharmaceutic% 0( Pharmaceutical Technolo,&

Semester- &&

%ame o! Su0DectE A+)ance Dru, Deli)er&?I 'Theor&( 'S-eciali.ation?III( Su0Dect CodeE PG$P0//
Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam Hrs

(6aluatio

Marks Hrs Marks / PG$P0// A+)ance Dru, Deli)er&?I 3 0 B /0 /0 1A /.4 <A

Ma /AA

T($C#&%. ('$E"$T&@% SC#(M(-- @<F(CT&'(S043( To ,et ac9uainte+ *ith A+)ancement in no)el +ru, +eli)er& %&%tem%" in term% of it% formulation %trate,ie%" e)aluation -arameter% an+ a--lication.

P)()(C"&S&T(S-044( 8a%ic 7no*le+,e in 8io -harmaceutic%" -harmaco7inetic% D 5a%ic% of

+ru, +eli)er& in 5o+&. 04B( 04<( Fun+amental un+er%tan+in, of 5io%tati%tic% 8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent.

C@")S( @"TE&%(Sr, C@")S( C@%T(%TS #@")S AF

%o 1 @ral sustained release Drug Deli6ery Systems (DDS)Ph&%ico chemical an+ 8iolo,ical factor% influencin, +e%i,n" +i%%olution controlle+ %&%tem%" Diffu%ion controlle+ %&%tem%" 8ioero+i5le %&%tem%" O%moticall& controlle+ %&%tem%" Ion E6chan,e %&%tem%. Ga%tro Retenti)e DDS" A+)ancement in ca-%ule +ru, +eli)er&"

Polymers in drug deli6eryPol&mer cla%%ification%" 5io+e,ra+a5le an+ non 5io+e,ra+a5le -ol&mer% an+ their a--lication% in controlle+ relea%e. Mucoadhesi6e Drug Deli6ery SystemsPh&%iolo,& of muco%a" mechani%m of tran%muco%al -ermeation. Deli)er& throu,h Ga%tro inte%tinal" 5uccal" rectal an+ )a,inal route%" 'ItJ% formulation %trate,ie% D e)aluation( Transdermal Drug Deli6ery SystemsFun+amental of %7in -ermeation" A--roach for +e)elo-ment" 7inetic e)aluation" formulation +e%i,n D o-timi.ation" A+)ancement in TDDS &mplants and &nsertsIntro+uction" Reaction of o%t to Im-lant" Reaction of Im-lant to o%t" %u5cutaneou% Im-lant%" Intra mu%cular im-lant%" Intra ocular im-lant%"

A4

AF

AB

A1

Intra )a,inal In%ert%" Intra uterine im-lant% %o6el ocular drug deli6ery systemsE Ocular thera-eutic% an+ con%traint% to effecti)e +eli)er&" formulation con%i+eration% to im-ro)e the ocular 5ioa)aila5ilit&" ocular in%ert% inclu+in, in%olu5le an+ %olu5le in%ert%" non?corneal route% an+ their u%e

AB

for %&%temic +ru, +eli)er&. Miscellaneous sustained Drug Deli6ery Systems- Pul%atile Dru, A4 Deli)er& S&%tem%" -atente+ technolo,& 'Rin, ca- Technolo,&" Li9ui+ %u%taine+ relea%e %&%tem% 'Sol to ,el %&%tem( etc. Pac;age de6elopmentPac7a,e t&-e% for +ifferent +o%a,e form%" -ac7a,in, material%" la5ellin," -reformulation %creenin, of -ac7a,e com-onent%. Systematic @ptimiJation o! Pharmaceutical Formulation Total

A<

/0 BA

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutic% D Pharmaceutical Technolo,& DisciplineE /( Pharmaceutic% 0( Pharmaceutical Technolo,& Semester- && %ame o! Su0DectE A+)ance Dru, Deli)er&?I 'Practical( 'S-eciali.ation?III( Su0Dect CodeE PG$P0//P
Detailed Sylla0us (Practical)- To illu%trate the to-ic% inclu+e+ un+er theor& E($)%&%. @"TC@M(S04F( #ith hel- of ,aine+ 7no*le+,e %tu+ent% can han+le re%earch -ro;ect in

no)el +ru, +eli)er& %&%tem% in hi%@her +i%%ertation *or7 D in -harmaceutical in+u%tr&. 04C( T($C#&%. Stu+ent can 5e a5le to o-timi.e -harmaceutical formulation u%in, De%i,n E($)%&%. M(T#@D@E@.Yof E6-eriment%

0BA( Facult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia -ro;ector 0B/( The cour%e em-lo&% lecture% an+ cla%% +i%cu%%ion%. It al%o inclu+e% -re%entation 5& %tu+ent% on a %-ecific to-ic a%%i,ne+ to them 5& the facult&. 0B0( Pre%entation on a ca%e relate+ to the cour%e.

<@@IS )(C@MM(%D(D-0B1( Enc&clo-e+ia of Pharmaceutical Technolo,&" >a%me% S*ar5ric7 an+ >ame%

C. 8o&lan" $arcel De77er Inc." Ne* Yor7.

0B3(

Theor& an+ Practice of In+u%trial Pharmac&" L. Lachman" !ar,i%h

Pu5lication" 8om5a&. 0B4( $o+ern Pharmaceutic%" G.S. 8an7er an+ C.T. Rho+e%" $arcel De77er"

Inc." Ne* Yor7. 0BB( Controlle+ Dru, Deli)er& E >. R. Ro5in%on an+ !. . Lee" $arcel De77er"

Inc." Ne* Yor7. 0B<( Yor7. 0BF( Pro,re%% in Controlle+ an+ No)el Deli)er& S&%tem%" e+ite+ 5& N.L. >ain" No)el Dru, Deli)er& S&%tem%" Y.#. Chien" $arcel De77er" Inc." Ne*

C8S Pu5li%her% D Di%tri5utor%" Ne* Delhi. 0BC( Tar,ete+ D Controlle+ Dru, Deli)er&" S. P. !&a% an+ R. L. Lhar" C8S

Pu5li%her% D Di%tri5utor%" Ne* Delhi. 0<A( A+)ance% in Controlle+ an+ No)el Dru, Deli)er&" E+ite+ 5& N.L. >ain"

C8S Pu5li%her% D Di%tri5utor%" Ne* Delhi 0</( Pharmaceutical Do%a,e Form%E Di%-er%e %&%tem" !ol. I" II DIII"

Lier5erman . A. an+ Leon Lachman" $arcel De77er" Ne* Yor7 0<0( an+5oo7 of Pharmaceutical Controlle+ Relea%e Technolo,&" Donal+ L.

#i%e" $arcel De77er" USA.

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE 2ualit& A%%urance '2.A( Semester- &&

%ame o! Su0DectE $o+ern Pharmaceutical Anal&%i% 'Theor&( 'S-eciali.ation?III( Su0Dect CodeE PG$P01/
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam Marks Hrs / PG$P01/ $o+ern Pharmaceutical Anal&%i% 3 0 B /0 /0 1A /.4 University Exam Marks <A Hrs

@<F(CT&'(S-0<1( To ma7e %tu+ent% familiar *ith )ariou% mo+ern anal&tical metho+% u%e+ in -harmaceutical anal&%i%

P)()(C"&S&T(S--

0<3( 0<4(

A %tu+ent ha% 5a%ic 7no*le+,e of -harmaceutical anal&%i% A 8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent.

C@")S( @"TE&%(-Sr, %o / A--lication of anal&tical metho+% to -ro+uct o5taine+ throu,h ,enetic en,ineerin, " Amino aci+ %e9uence anal&%i%" Tr&-tic ma-in," ion e6chan,e amino aci+ anal&%i%" i%oelectric focu%in, etc. 0 Re,ulator& re9uirement in -harmaceutical anal&%i% N US?FDA" IC AF AB Course Content #ours

Soli+ %tate anal&%i% of +ru, %u5%tance inclu+in, relate+ %u5%tance%" an+ im-uritie% -re%ent in +ru,% an+ their effect on +ru, %ta5ilit& an+ thera-eutic action.

AB

A--lication% of )ariou% anal&tical techni9ue% in -reformulation anal&%i% an+ it% im-ortance.

A3

4 B < F C /A // /0

Anal&%i% of %oli+ oral +o%a,e form Anal&%i% of in;ecta5le +o%a,e form Com-en+ial te%tin, Automate+ anal&%i% Com-en+ial metho+% for e)aluation of cru+e +ru, an+ her5al formulation 2ualit& control of ra+io -harmaceutical% an+ ra+io chemical metho+ in anal&%i%. Anal&%i% of co%metic% Re,ulator& re9uirement for %ta5ilit& %tu+ie%E A )er& 5rief intro+uction to FDA an+ # O ,ui+eline%. Detail %tu+& of IC 2/E" 2/F" 24C(. ,ui+eline% '2/A 'R0(" 2/8" 2/C" 2/D"

A3 A3 A1 A0 A0 A1 A1 A4

/1

Linetic -rinci-le% a--lie+ for %ta5ilit& e)aluation an+ their a--lication% in -re+ictin, %helf life an+ half life of -harmaceutical formulation%. Im-ortance of accelerate+ %ta5ilit& %tu+&.

AF

/3

Sta5ilit& in+icatin, a%%a&. Total

A0 4:

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE 2ualit& A%%urance '2.A( Semester- && %ame o! Su0DectE $o+ern Pharmaceutical Anal&%i% 'Practical( 'S-eciali.ation?III( Su0Dect CodeE PG$P01/P
Detailed Sylla0us (Practical)

0<B( 0<<( 0<F( 0<C( 0FA( 0F/( 0F0( 0F1( 0F3( 0F4(

A%%a& of I5u-rofen Ta5let I.P." Tol5utami+e Ta5let I.P." Calcium Lactate an+ Determination of #ater in Sor5itol" So+ium Citrate D Am-icillin. Determination of Total Chlori+e in Thiamine Chlori+e &+rochlori+e. 2ualit& control Te%t% for Ta5let%" Ca-%ule%" In;ection%" Ointment% an+ Detection an+ Determination of Pre%er)ati)e%" Antio6i+ant% an+ Colourin, Determination of relate+ %u5%tance% in Al5en+a.ole" Amilori+e" $etroni+a.ole" 8etametha.one" Car5ama.e-ine" Diclofenac" E-he+rine" I5u-rofen" Paracetamol" Determination of acti)e con%tituent% in cru+e +ru,%. E.G. Caffiene from tea 2ualit& Control te%t% for %ome her5al formulation%. 2ualit& Control te%t% for %ome co%metic%.

Ferrou% Fumerate I.P.

Su--o%itorie%. material% in Pharmaceutical%

Eucal&-tu% oil" Phen&l5ar5itone an+ Sul-hafura.one" Rifam-icin a% -er I.P. -o*+er" curcumin from curcuma lon,a" 9uinine from cinchona 5ar7 etc.

E($)%&%. @"TC@M(S--

0FB(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to un+er%tan+ the mo+ern

anal&tical techni9ue%" *hich i% im-ortant for -harmaceutical anal&%i% of )ariou% +o%a,e form" cru+e +ru, an+ her5al formulation.

T($C#&%.

E($)%&%. M(T#@D@E@.Y-Facult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia

0F<(

-ro;ector.

)(C@MM(%D(D <@@IS-

0FF( 0FC( 0CA( 0C/( 0C0( 0C1( 0C3( 0C4( 0CB(

arr& G 8rittain" S-ectro%co-& of Pharmaceutical Soli+%" Dru,% S. Ahu;a" $o+ern Pharmaceutical Anal&%i%. Lena Ohanne%ian an+ Anthon& >. Streeter"

an+

Pharm Sci.Serie%"!ol. /BA" Ta&lor an+ Franci%" 0AAB N.Y. an+ 8oo7 of Pharmaceutical

Anal&%i%" Pharm Sci. %erie%" !ol. //<" $aarcel De77er Inc." N.Y. Pe-ti+e an+ Protein Dru, Anal&%i%" 5& Rei+" '$arcel De77er(. Cla%%ification of co%metic% ra* material% an+ a+;unct% IS 1C4F of In+ian Co%metic an+ toilet ,oo+% N metho+% of %am-lin, IS 1C4F of In+ian $etho+% of %am-lin, an+ te%t for )ariou% co%metic% a% lai+ +o*n 5& In+ian In+ian Pharmaco-oeia"!ol. I an+ !ol. II ? /CCB.The Controller of The International Pharmaco-oeia !ol /"0"1"3" 1r+ E+ition General

Stan+ar+% In%titution '8IS(. Stan+ar+% In%titution '8IS(. Stan+ar+ In%titution '8IS(. Pu5lication%: Ne* Delhi" Go)t. of In+ia" metho+% of anal&%i% an+ 9ualit& %-ecification% for -harmaceutical %u5%tance%" e6ci-ient%" +o%a,e form%. 0C<( 2ualit& A%%urance of Pharmaceutical% N A com-en+ium of ,ui+eline% an+

relate+ material% !ol./ an+ !ol.0" # O" '/CCC(. 0CF( 0CC( 1AA( 1A/( 1A0( 1A1( 1A3( 8a%ic te%t% for -harmaceutical %u5%tance% N # O '/CFF( 8a%ic te%t% for -harmaceutical +o%a,e form% N # O '/CC/( Ph&tochemical $etho+% 5& >.8. aro5orne Pharmaco-oeal %tan+ar+% for A&ur)e+ic Formulation 'Council of Re%earch Chemical Sta5ilit& of Pharmaceutical%?A Sta5ilit& te%tin, of +ru, Pro+uct% 5& #.Grimm. Sta5ilit& of Dru,% an+ +o%a,e form 5& Yo%hio7a an+ %tella. an+5oo7 for Pharmaci%t%"

in In+ian $e+icine D omeo-ath&(. Lenneth Connor%" >ohn #ile& D Son%" Inc.

(-)(S@")C(S--

1A4( 1AB( 1A<( 1AF( 1AC(

***.!da.,o)@+o*nloa+%@Dru,%@Gui+ance%@ucmA<14/<.-+f ***.!da.,o)@+o*nloa+%@Dru,%@...@Gui+ance%@ucmA<14A<.-+f ***.i-a-harma.or,@e)ent%@sta0ility@$ilin+=0A>o%hi.-+f a##s.w"o.int/#re$ual/.../#$.../&-2%RegulatoryRequirements.##t ***.ich.or,@filea+min@...@&C#...@.uidelines@...@2/EX.uideline.-+f

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE /. 2ualit& A%%urance '2.A( 0. Pharmaceutical Anal&%i% Semester- && %ame o! Su0DectE Total 2ualit& $ana,ement D Documentation 'Theor&( 'S-eciali.ation?I!( Su0Dect CodeE PG$P010
Teaching (6aluation Scheme--

Teaching Scheme (#ours8*ee;) Theory Sessional Exam Marks Hrs / PG$P010 Total 2ualit& $ana,ement D Documentation 3 0 ? B AB 1A /.4 University Exam Marks <A Hrs

@<F(CT&'(S--

1/A( 1//( 1/0(

To -ro)i+e the %tu+ent *ith un+er%tan+in, of the role of 9ualit& mana,ement an+ To intro+uce D 5uil+ on the conce-t of 9ualit& in Pharmac& -rofe%%ion To e6-an+ the conce-t of 9ualit& at in+u%trial le)el" inclu+in, -lant +e%i,n @

it% im-lementation *ithin the -harmaceutical in+u%tr&.

la&out"en)ironmental control%" etc.

P)()(C"&S&T(S--

1/1(

A 8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent.

C@")S( @"TE&%(-Sr. N o 1 2ualit&E Conce-t of 9ualit&" nature of -ro+uct 9ualit&" %tu+& of )ariou% a--roache% for 9ualit& li7e Demin,J" >uran" Cro%5&" Fei,en5aum" Shi7a*a. 2 Conce-t% an+ Princi-le% of T2$E .1 Cu%tomer 2 Ne)er en+in, im-ro)ement 3 Control of 5u%ine%% -roce%% 4 U-%tream -re)enti)e mana,ement A< AB o!rse ontents Ho! rs

5 On,oin, -re)enti)e action 1 6 Lea+er%hi- an+ team*or7 2ualit& tool% for T2$E Pie chart% D 5ar ,ra-h%" hi%to,ram%" run chart%" -areto chart%" force fiel+ anal&.er" 5rain %tormin, D affinit& +ia,ram%" tree +ia,ram%" flo* chart% D mo+ellin," %catter +ia,ram an+ relation% +ia,ram. 4 3 Other a--roache% of 9ualit& mana,ementE ISO CAAA %erie%. In Proce%% 9ualit& control% on )ariou% +o%a,e form%E Ta5let%" ca-%ule%" li9ui+ oral%" in;ecta5le%" aero%ol%" %emi%oli+% '%terile an+ non%terile(. 4 Pharmaceutical -lant +e%i,nE 1 Re,ulator& re9uirement% of Pharma facilitie% *ith reference to cG$P 2 De%i,n of 2.C. La5orator& 5 3 De%i,n of effluent treatment -lant $aterial Safet& Data Sheet '$SDS( -re-aration Stan+ar+ in%titute% D certification a,encie% li7e ISI" 8SS" AST$" # O" US?FDA" UL?$CA" TGA :7 Pre-aration of +ocument% for Ne* Dru, A--lication 'NDA( a% -er re9uirement% of FDA an+ EUDRA ,ui+eline%. G$P re9uirement% for FDA" PIC an+ IC . Site $a%ter File%" Out of %-ecification. Sta5ilit& %tu+ie% a% -er IC " EUDRA" FDA" Anal&tical $etho+olo,& :9 armoni.ation of re,ulator& re9uirement%E Stu+& of IC +ocument%. armoni.ation of Pharmaco-oeial %tan+ar+%. /: 2ualit& 5& De%i,n '25D( an+ Proce%% anal&tical technolo,& 'PAT( a--roach Total A4 BA common technical A3 A< AC A4 A3 A< AB

E($)%&%. @"TC@M(S--

1/3(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to un+er%tan+ the 9ualit&

mana,ement S&%tem" in -roce%% 9ualit& control that contri5ute% to the control" 9ualit& an+ )ali+it& of a Pro+uct an+@or %er)ice.

1/4(

The %tu+ent *ill al%o ac9uire the information re,ar+in, the -harmaceutical -lant

an+ +e%i,n o-eration.

T($C#&%.

E($)%&%. M(T#@D@E@.Y-Facult& mem5er@% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia It al%o inclu+e% -re%entation 5& a %tu+ent% on a %-ecific to-ic a%%i,ne+ to them 5&

1/B( 1/<(

-ro;ector. the Facult&. )(C@MM(%D(D <@@IS-

1/F( 1/C( 10A( 10/( 100( 101( 103( 104( 10B(

Delhi.

Gnarino Richar+ A" Ne* Dru, A--ro)al Proce%%" 1 r+ E+." $arcel De77er Inc. Total 2ualit& $ana,ement? Gui+in, Princi-le for A--lication" >. P. Pe7er" AST$ Total 2ualit& $ana,ement N The Le& to 8u%ine%% Im-ro)emetn" Cham-man D all" Lon+an. 2ualit& A%%urance Gui+e 5& Or,ani%ation of Pharmaceutical -ro+uct% of In+ia. A ,ui+e to Total 2ualit& $ana,ement N Lau%hi7 $aitra an+ Se+han L.Gho%h. ISO CAAA an+ Total 2ualit& $ana,ement N Sa+han7. G. Gho%h. Pro;ect $ana,ement" Cliffor+ F. Gra& an+ Eri7 #." Lar%on Pu5li%herE $cGra* ill Com-an&. Pharmaceutical Pro+uction facilitie%E De%i,n an+ a--lication%" Graham Cole" Pro+uction@O-eration% $ana,ement" El *oo+ 8ufa" #ile& Ea%tern Limite+" Ne* Plannin, an+ control" Samuel Eilon" Uni)er%al 5oo7 cor-oration" $um5ai. Goo+ Dru, Re,ulator& Practice%E a Re,ulator& Affair% 2ualit& $anual 'Goo+ FDA Re,ulator& Affair%E A Gui+e for Pre%cri-tion Dru,%" $e+ical De)ice% an+ $e+ical Pro+uct Re,ulator& Affair%E Pharmaceutical " Dia,no%tic%" $e+ical The Pharmaceutical Re,ulator& Proce%%" 0n+ e+. N Ira R. 8err&" Ro5ert P. $artin.

manual %erie%" Phila+el-hia.

Pu5li%her Ta&lor D Franci%.

10<( 10F( 10C( 11A( 11/(

Dru, De)elo-ment Serie%( N elene I. Dumitriu 8iolo,ic%" 0n+ e+. N Dou,la% >. Pi%ano an+ Da)i+ S. $antu%. De)ice% N >ohn >. To5in an+ Gar& #al%h

(-resouces

110( 111( 113( 114( 11B(

***. mhra.,o).u7 ***.t,a.,o).au ***.u%f+a.or, ***.a%tm.or, ***.5%i,rou-.com

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE Pharmaceutical Anal&%i% Semester- && %ame o! Su0DectE Pharmaceutical Anal&%i%?I 'Theor&( 'S-eciali.ation?III( Su0Dect CodeE PG$P03/
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional (2am Mar;s / PG$P03/ Pharmaceutical Anal&%i%?I 3 0 B /0 /0 1A #rs /.4 "ni6ersity (2am Mar;s <A #rs

(6aluatio

Se

M /AA

@<F(CT&'(S--

11<(

To ma7e %tu+ent% familiar *ith e)aluation of +ru,% an+ co%metic% 5& )ariou%

metho+olo,ie% in -harmac&. P)()(C"&S&T(S--

11F(

8. Pharm. +e,ree from an& AICTE a--ro)e+ in%titution or it% e9ui)alent

C@")S( @"TE&%(--

Sr, %o /

Course Contents

#ours

General metho+ of anal&%i% to +etermine the 9ualit& of ra* material% u%e+ in co%metic in+u%tr&

$etho+% of anal&%i% to +etermine the 9ualit& of co%metic% in the fini%he+ form% %uch a% air care -ro+uct%" S7in care -ro+uct%" 8a5& care -ro+uct%" Dental -ro+uct%" Per%onal h&,iene -ro+uct%" Colour co%metic%" Ethnic -ro+uct%" Colour ma7eu- -re-aration" Li-%tic7%" air %ettin, lotion% an+ E&e %ha+o*%.

2uantitati)e e%timation of follo*in, functional ,rou-%

A.

&+ro6&l

8. E%ter C. Amine D. al+eh&+e E. Car5o6&lic aci+

4

I+entification an+ 9uantitati)e +etermination of -re%er)ati)e%" Antio6i+ant%" colourin, material%" emul%ifier% an+ %ta5ili.er% in Pharmaceutical formulation *ith ca%e %tu+ie%

3 4

2ualit& control of Ra+io-harmaceutical% Soli+ %tate anal&%i% of +ru, %u5%tance inclu+in, a +etaile+ %tu+& on relate+ %u5%tance% an+ im-uritie% -re%ent in +ru,% an+ their effect on +ru, %ta5ilit& an+ thera-eutic action" *ith ca%e %tu+ie

4 5

Intro+uction to harmoni.ation an+ IC " 5rief a5out IC Gui+eline% *ith %-ecial con%i+eration of 2/ an+ 20

Im-urit& -rofilin,E u%e of LC?$S" LC?IR" LC?N$R. Ca%e Stu+ie%E Im-urit& -rofilin," I%olation an+ Characteri.ation

9 /:

Sta5ilit& in+icatin, a%%a& *ith ca%e %tu+ie% 2ualit& control te%t of container% ',la%%" -la%tic%" -a-er( " la5el%" la5el a+he%i)e" carton% Total

4 4

4:

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmaceutical Chemi%tr& D Pharmaceutical Anal&%i% DisciplineE Pharmaceutical Anal&%i% Semester- && %ame o! Su0DectE Pharmaceutical Anal&%i%?I 'Theor&( 'S-eciali.ation?III( Su0Dect CodeE PG$P03/
Detail sylla0us (Practical)

11C( 13A( 13/( 130( 131( 133( IP 134( 13B(

Ph&%ical %ta5ilit& te%tin, of +o%a,e form Soli+% N Ta5let%" Ca-%ule%" Po*+er% D Granule% Emul%ion% an+ Su%-en%ion% Photo %ta5ilit& %tu+& of +ru, an+ -harmaceutical% 2C te%t for her5al formulation% an+ her5al in,re+ient% Determination of relate+ %u5%tance% in %ome API an+ formulation% a% -er De)elo-ment an+ )ali+ation of %imultaneou% metho+ for +etermination of 2uantitati)e e%timation of follo*in, functional ,rou-% A. 8. C. D. E. &+ro6&l E%ter Amine Al+eh&+e Car5o6&lic aci+

t*o +ru,% 5& U! %-ectrometr&

E($)%&%. @"TC@M(S--

13<(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to learn the 5a%ic techni9ue% to

e)aluate +ru,% an+ co%metic%.

T($C#&%.

E($)%&%. M(T#@D@E@.Y- Lecture% 5& u%in, 5lac7 5oar+ an+ Po*er -oint Pre%entation" !i%ual Gra-hic%"

13F(

Practical +emon%tration% an+ Practical *or7in,.

<@@IS )(C@MM(%D(D--

13C( 14A( 14/( 140( 141( 143( 144( 14B( 14<( 14F( 14C(

# O ,ui+eline% for 9ualit& control of her5al -lant material% IC ,ui+eline% for im-urit& +etermination an+ %ta5ilit& %tu+& IC 2/ an+ 20 ,ui+eline% In+ian -harmaco-oeia )olume / to 1 Dru, %ta5ilit& E Princi-le% an+ -ractice% 5& >en% T. Car%ten%en Pharmaceutical Do%a,e Form De%i,nE Ta5let%? !ol I"II D III 5& Lachmann. Theor& an+ Practice of In+u%trial Pharmac& 5& Lachman. Sta5ilit& Te%tin, of Dru, Pro+uct% 5& #.Grimm. $artin Ph&%ical Pharmac& N I!th E+ition. Ph&%ical Pharmaceutic% 5& $ana)alam an+ Rama%*am&. Sta5ilit& of Dru,% an+ Do%a,e Form% 5& Yo%hio7a an+ Stella.

(-)(S@")C(S--

1BA( 1B/(

Re%earch an+ Re)ie* article% from El%e)ier ;ournal% Re%earch an+ Re)ie* article% from ***.%cience+irect.com

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmacolo,& D To6icolo,&

DisciplineE Pharmacolo,& Semester- && %ame o! Su0DectE $etho+% in Pharmacolo,& 'Theor&( 'S-eciali.ation?III( Su0Dect CodeE PG$P04/
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam University Exam Hrs

(6alu

Marks Hrs Marks / PG$P04/ $etho+% in Pharmacolo,& 3 0 B /0 /0 1A /.4 <A

/AA

@<F(CT&'(S- To train in all the a%-ect% of +ru, e)aluation to con+uct -harmacolo,ical e6-eriment in+e-en+entl&. To ma7e %tu+ent% familiar *ith metho+olo,& in +ru, %creenin, a% *ell a% ne*er a--roache% in +ru, +i%co)er& -roce%%.

P)()(C"&S&T(S--

1B0(

Lno*le+,e of %ome 5a%ic% of Pharmcolo,ical e)aluation in la5orator& animal%

C@")S( @"TE&%(-Sr, %o 1 <iological StandardiJationGeneral -rinci-le%" Im-ortance" %co-e% an+ limitation% of 8ioa%%a&" $etho+% in 5ioa%%a&" 8ioa%%a& of official +ru,% A4 Course Content #rs

Preclinical (6aluation o! DrugTo6icit& %tu+& 'Acute" %u5?acute an+ chronic(" ED4A an+ LD4A +etermination" S-ecial to6icit& %tu+& li7e terato,enicit& an+ muta,enecit&. !ariou% ,ui+eline% for to6icit& %tu+ie%. Preclinical Safet& A%%e%%ment te%t% inclu+in, carcino,enicit& an+ re-ro+ucti)e %tu+ie%.

A4

%e+er $pproaches in Drug Disco6ery Process. Com5inatorial chemi%tr&" throu,h-ut %creenin," Ultra i,h throu,h-ut %creenin,"

i,h

AC

Pharmaco,enomic%"

Proteomic%" Arra& technolo,&" In)itro -harmaco7inetic anal&%i%" In)itro In)i)o Correlation 'I!I!C(" In Silico A--roach 4 <iological (6aluation o! DrugGeneral Princi-le of %creenin," +e)elo-ment% of mo+el% 'In )i)o" In )itro" E6 )i)o" In %ilico(" E)aluation $etho+% of follo*in,% +ru,%E 2 Anti?h&-erten%i)e +ru,%" Anti?athero%clerotic +ru,%" Anti?arrh&thmic +ru,%" Anti? an,inal +ru,%" Dru, u%e+ in Car+iac Failure 3 Para%&m-athomimetic%" Para%&m-athol&tic%" S&m-athomimetic%" S&m-athol&tic%" Dru, actin, on neuromu%cular ;unction an+ ,an,lia 4 Dru, u%e+ in E-ile-%&" Par7in%oni%m" An6iet&" De-re%%ion" P%&cho%i% an+ Al.heimerJ% +i%ea%e. 5 Dru, u%e+ in Pe-tic ulcer" Diarrhoea" A%thama" Dia5ete%" O5e%it&" Infertilit&" Cancer an+ Diuretic% 6 CNS %timulant% an+ +e-re%%ant%" Anal,e%ic% an+ +ru,% u%e+ in Inflammation an+ Arthriti%. 5 7 !ariou% mo+el% for Glaucoma" I8D" e-atic +i%ea%e% TechniHues !or the study o! Molecular Pharmacology %uch a% #e%tern 8lottin," Immuno%tainin," RT?PCR" Clonin," RIA" Cell Culture% etc. A4 1B

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmacolo,& D To6icolo,& DisciplineE Pharmacolo,& Semester- && %ame o! Su0DectE $etho+% in Pharmacolo,& 'Practical( 'S-eciali.ation?III( Su0Dect CodeE PG$P04/P
Detail Sylla0us (Practical)

1B1(

8ioa%%a& of a,oni%t 'Gra-hical" $atchin," Three -oint" Four -oint( an+ 8ioa%%a&

of anta,oni%t u%in, i%olate+ ti%%ue%

1B3( 1B4(

To6icit& %tu+ie% E)aluation of +ru,% 5a%e+ on theor& %&lla5u%

E($)%&%. @"TC@M(S--

1BB(

At the en+ of the cour%e" %tu+ent *ill 5e a5le to learn the 5a%ic techni9ue% to

e)aluate +ru,% u%in, )ariou% animal mo+el% for +ifferent -atholo,ical con+ition%.

T($C#&%.

E($)%&%. M(T#@D@E@.Y--

Facult& mem5er% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia -ro;ector.

<@@IS )(C@MM(%D(D--

1B<( 1BF( 1BC(

NY.

.G. !o,el" 0AA0. SDru, Di%co)er& an+ E)aluation?Pharmacolo,ical A%%a&%T" D.R. Laurence an+ A.L. 8acharach" /CB3. SE)aluation of Dru, Acti)itie%E Ro5ert A. Turner" /C</. SScreenin, metho+% in -harmacolo,&T" Aca+emic -re%%" A. Sch*art." S$etho+% in Pharmacolo,&T.Plenum Pu5li%hin, Cor-oration. >. . 8urn" D.>. Finne& an+ L.G. Goo+*in" S8iolo,ical %tan+ar+i.ationT 0n+ e+. In+ian Pharmaco-oeia " Go)t of In+ia -re%%0AAC. U%ha G. Lamat" Da+7ar" N.L" Seth" SSelecte+ to-ic% on the E6-erimental $.N Gho%h" SFun+amental% of e6-erimental Pharmacolo,&T 0AA<" iltton

0n+ E+. S-rin,er !erla," 8erlin" German&. Pharmacometeric%T !ol. / an+ 0" Aca+emic Pre%%" Lon+on" U.L.

1<A( 1</( 1<0( 1<1( 1<3( 1<4( 1<B( 1<<( 1<F( 1<C(
0AA/

O6for+ Uni. Pre%%" /C4A

Pharmacolo,&T U.L." /C<0. Com-an& " Lol7ata. L. >. $c Leo+" SPharmacolo,ical e6-eriment on intact -re-aration%T Churchill Sha&ne Co6 Ga+ an+ Chri%to-her P" SAnimal mo+el% in to6icolo,&T The UFA# an+5oo7 on the care an+ mana,ement of la5orator& an+ other Li)in,%tone./C<A Chen,eli%.0AAB" Informa ealthCare. Re%earch animal% 5& UFA#. Fth e+."0A/A" #ile&?8lac7*ell a&e%" SPrinci-le% an+ metho+% of to6icolo,&T 3th e+." 0AA/" Ta&lor D Franci% Derelan7o an+ ollin,er" SCRC an+5oo7 of to6icolo,&T 0n+ e+." CRC Pre%%

(-)(S@")C(S--

1FA( 1F/( 1F0( 1F1( 1F3( 1F4(

htt-E@@ci+.o6for+;ournal%.or,@content@11@Su--lementX1@S0/3.full ***.ia,im.or,@-+f@i)i)c?A/.-+f ***.+i%%olutiontech.com@DTre%our@...@DT0AA<A0XAA0.-+f ***.ual5erta.ca@Yc%-%@>PPSCX0@>a5er...@/CAXRe)i%e+XFinalXre)0.-+ ***.5entham%cience.com@o-en@to++;@article%@!AA3@...@1FTODD>.-+f ***.aca+emic;ournal%.or,@;5%a@PDF@...@Rao=0Aan+=0ASrini)a%.-+f

1FB( 1F<( 1FF(

htt-E@@***.nc5i.nlm.nih.,o)@-mc@article%@P$C/C<F0<3@ htt-E@@***.-iercenet.com@5ro*%e.cfmVfl+IDGF04CA<8B?<DAB?3/CF?CD44? htt-E@@***.nc5i.nlm.nih.,o)@-u5me+@/B3F1<C3

AABC/3F1//C1

C. U. S A UNI!ERSITY
#AD #ANCITY
FacultyE ? Pharmaceutical Science% DepartmentE Pharmacolo,& D To6icolo,& DisciplineE Pharmacolo,& Semester- && %ame o! Su0DectE A+)ance+ Pharmacolo,&?II 'Theor&( 'S-eciali.ation?I!( Su0Dect CodeE PG$P040
Teaching (6aluation Scheme-Teaching Scheme (#ours8*ee;) Theory Sessional Exam Mar;s / PG$P040 A+)ance+ Pharmacolo,&?II 3 0 ? B AB 1A #rs /.4 University Exam Mar;s <A #rs

(6aluation

Se

Ma /AA

@<F(CT&'(S- To im-act 7no*le+,e a5out late%t +ru,% a)aila5le for thera-eutic%. To 5rain the %tu+ent in recent tren+% in +ru, thera-& for )ariou% +i%ea%e% *ith re%-ect to $OA +o%a,e" a+)er%e effect%. P)()(C"&S&T(S- Lno*le+,e a5out the 5a%ic% of -harmacolo,&.

C@")S( @"TE&%(-Sr, Course Contents #rs

%o The s /&ect sho ld ,i0e e$)hasis on recent trends and ad0ances in the "ollo'in, classes o" dr ,s1 C%S Pharmacotherapeutics- Neuro+e,enerati)e +i%ea%e% 'Par7in%onJ% +i%ea%e" Al.heimerJ% +i%ea%e" untin,tonJ% chorea(" 8eha)iour +i%or+er% 'An6iet&" In%omnia" De-re%%ion an+ $ania(" P%&cho%e%" E-ile-%&" $i,raine 2 Cardio6ascular PharmacotherapeuticsDi%li-i+emia 3 "rogenital PharmacotherapeuticsRenal Failure" Infertilit&" $eno-au%e" AF &-erten%ion" An,ina -ectori%" Con,e%ti)e /A /0

eart Failure" Arrh&thmia%" Acute coronar& %&n+rome" Throm5oem5olic +i%or+er%"

D&%menorrheoa" 8eni,n Pro%tatic &-er-la%ia 4 .& Pharmacotherapeutics- Pe-tic Ulcer" Inflammator& 8o*el Di%ea%e" Li)er Di%ea%e" !omitin," Diarrhoea" Con%ti-ation" Aclorh&+ria 5 (ndocrine Pharmacotherapeutics- Dia5ete%" Di%or+er% of Parath&roi+ ,lan+" Di%or+er% of th&roi+ ,lan+" A+renocortical +&%function 6 )espiratory Pharmacotherapeutics- 8ronchial A%thma" COPD" Aller,ic Rhiniti%" Common col+" Cou,h" C&%tic fi5ro%i% 7 @ccular Pharmacotherapeutics- Gluacoma" Cataract Total A1 BA A< /A /A

E($)%&%. @"TC@M(S--

1FC(

At the en+ of the cour%e" the %tu+ent *ill 5e a5le to un+er%tan+ the Pharmacolo,&"

Patho-h&%iolo,& an+ Thera-eutic 5a%i% of +ru, treatment.

T($C#&%.

E($)%&%. M(T#@D@E@.Y--

Facult& mem5er% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia -ro;ector.

<@@IS )(C@MM(%D(D--

1CA( 1C/( 1C0( 1C1( 1C3( 1C4( 1CB( 1C<(

ar+man >. G." Lim5ir+ L. E. 0AA/. SGoo+man an+ GilmanJ% The Da)i+ E. Golan" SPrinci-le% of Pharmacolo,&?The Patho-h&%iolo,ic 5a%i% of . P. Ran, an+ $. $. Dale" SPharmacolo,&T 4th E+. Churchill Li)in,%tone. Paul L. $un%on" SPrinci-le% of Pharmacolo,&. >ame% Cro%%lan+" SLe*i%J% Pharmacolo,&T Churchil Li)in,%tone. Po%e-h T. Di-iro" SPharmacothera-&?A -atho-h&%iolo,ical a--roachT Crai," Charle% R." S$o+ern Pharmacolo,& *ith clinical a--lication%T .L. Sharma" SPrinci-le% of Pharmacolo,&T

Pharmacolo,ical 8a%i% of Thera-eutic%T /Ath E+.$cGra*? ill Profe%%ional. +ru, thera-&T 0n+ E+. Li--incott #illiam% D #il7in%.

(-)(S@")C(S--

1CF( 1CC( 3AA( 3A/( 3A0( 3A1( 3A3(

htt-E@@***.lifee6ten%ion)itamin%.com@cataract%-art0.html htt-E@@***.nc5i.nlm.nih.,o)@-u5me+@BACBAC4 htt-E@@***.%cience+irect.com@%cience@article@-ii@SACBFBA41A/CAAFF0 ccn.aacn'ournals.org/content/25/ / (.full.#df htt-E@@***.nc5i.nlm.nih.,o)@-u5me+@0/43<<01 htt-E@@***.m+)u.or,@li5rar&@+i%ea%e@h+@h+X-ath.a%htt-E@@***.me+%ca-e.or,@)ie*article@<4C0C0