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Albany College of Pharmacy

Pharmacokinetics PHM 421 Fall 2007

Course Instructors
Adwoa O. Nornoo, PhD. (Course Coordinator); Assistant Professor of Pharmaceutics,
Department of Pharmaceutical Sciences, Albany College of Pharmacy, PRI 201A; & by
appointment (via email), Phone: (518)694-7352, E-mail: nornooa@acp.edu

Shannon Miller, PharmD; Assistant Professor of Pharmacy Practice, Department of


Pharmacy Practice, Albany College of Pharmacy, OB201B, Phone: (518) 694-7138;
millers@acp.edu

Teaching Assistants
Samuel Evang, PharmD Candidate
Neona Tu, PharmD Candidate
Gashaw Teferi, PharmD Candidate

Lecture Schedule: M/W 2:00 – 3:20 pm in SC 201

Course Description
Pharmacokinetics is the study of the mathematical time course of absorption,
distribution, metabolism and elimination (ADME) in the body using compartmental
and non-compartmental analysis; topics include general concepts of one- and two-
compartment models, linear and nonlinear pharmacokinetics and statistical moment
theory. Emphasis is placed on determination of pharmacokinetic parameters from
plasma/urine data following administration of single or multiple intravenous bolus
injections, intravenous infusion and oral administration. Additionally, the course
includes the study of bioavailability and bioequivalence of drug products,
pharmacokinetic-pharmacodynamic correlations, and adjustment of dosing regimen
in patients with renal and hepatic impairment.

Course Material
A. Lecture notes - Blackboard (includes practice problems and keys).
B. Required Textbook: Clinical Pharmacokinetics by Malcolm Rowland and Thomas
N. Tozer, 3rd Edition, 1995 (A copy will placed on ‘reserve’ in the library)
C. Recommended Textbooks:
• Applied Biopharmaceutics and Pharmacokinetics by Leon Shargel, Susanna Wu-
Pong and Andrew B.C. Yu, 5th Edition, 2005,
• Pharmacokinetics: Principles and Applications by Mehdi Boroujerdi 1st Edition,
2002
• Introduction to Pharmacokinetics and Pharmacodynamics: The Quantitative
Basis of Drug Therapy by Thomas N. Tozer and Malcolm Rowland 1st edition,
2006.
D. Computer (bring power cord and internet cable, disable wireless feature)
E. Scientific Calculator: with logarithmic and exponential functions. Alphanumeric
programmable calculators will not be permitted during exams.
F. Graph Paper: Semi-log (3 and 4 cycles x 10 div/inch) and ruler. Download copies
from Blackboard.
Course Requirements and Grading Policies
1. Assigned questions from the required and recommended textbooks are posted
under each module in Blackboard.

2. Problem solving sessions will be offered at least two to four times every week.
Teaching assistants will solve problems and answer questions regarding the
problems solved.

3. Quizzes: (10% of final grade)


Six online quizzes will be given randomly throughout the semester. The lowest
quiz grade will be dropped and the average of 5 quizzes will be taken. No make-
up quizzes will be given.

4. Exams: (90% of final grade).


• Three midterm (20% each) exams will be given.
• Midterm exams will not be returned after grading. You will be allowed to
review your exams and any questions about exam grades must be resolved
within one week of grading. The instructor will retain the final exam, (30% of
final grade) but the exam will be available for review upon request.

No make-up exams will be given except in cases of documented medical


emergencies or absences approved at the discretion of the Instructor in advance.
All make-up exams will be different than the originals. Location and time of
make-up exams, format of exam are all at the discretion of the instructor. No
exceptions!

5. HONOR CODE: An Honor Code system has been adopted by the student body
and is published annually in the student handbook. All individuals involved with
this course are expected to have read the Honor Code Constitution and to abide
by its provisions. In the case of a cheating decision for a first offense, the
student will fail the course and will be placed on probation with an open letter
detailing the event placed in the student’s file. In the case of a cheating decision
for a second offense, the student will be expelled from the College and a letter
explaining the reason for the student’s expulsion will become part of the student’s
permanent record.

6. PROCEDURE FOR ADDRESSING COURSE CONCERNS: Students are


encouraged to discuss concerns about grading and other academic issues
with faculty according to the following sequence. The first step in the appeal
process is to discuss the concern with the faculty member directly involved. The
appeal process must be initiated within two weeks of the examination,
assignment or academic incident that is the subject of the appeal. If the
concern is not resolved satisfactorily through discussion with the faculty
member the student should consult the course coordinator. In the event that a
mutually acceptable resolution is not achieved with the course coordinator the
student may appeal in writing to Dr. Millington, acting chair of the Department of
Pharmaceutical Sciences. If the issue is still unresolved at this stage the student
may appeal in writing to Dean Denio, the associate dean for academic affairs.
The final step in the appeal process is to submit a written appeal, including any
supporting documents, to Dean Boroujerdi. The decision of the dean is final.
7. ELECTRONIC COMMUNICATIONS (CELL PHONE, PAGER AND
ELECTRONIC DEVICE) RESOLUTION: Be it resolved that cell phones and
pagers should be set to a non-audible mode (vibrate or flashing light) during
class (classroom or laboratory). Calls should not be answered until the class is
over, except in extenuating circumstances. Electronic devices, other than those
approved by the instructor, should not be used during examinations or classroom
instruction.

Grading:
All quizzes, midterm exams and final exam grades will be posted on Blackboard.

Quizzes 10 points
Exam I (10/01/2007) 20 points
Exam II (10/31/2007) 20 points
Exam III (11/28/2007) 20 points
Final Exam 30 points
TOTAL 100 points

A+ > 97
A 93-96
A- 90-92
B+ 87-89
B 83-86
B- 80-82
C+ 77-79
C 73-76
C- 70-72
D+ 67-69
D 63-66
D- 60-62
F <60

Schedule of Topics

TOPIC DATES
Module One: Introduction and Basic Concepts 9/05
Nornoo
Module Two: One- and Two- compartment Pharmacokinetic Model: 9/10, 9/12, 9/17
Intravenous Bolus Dose Nornoo

Module Three: One-Compartment Pharmacokinetic Model: Intravenous 9/19, 9/24


Infusion Nornoo

Exam I (20% of final grade) 10/01


9/26, 10/03, 10/10
Module Four: One-Compartment Pharmacokinetic Model: Extra vascular Dose Nornoo
Module Five: Multiple Dosing: IV Bolus Dose, Intermittent IV Infusion and 10/15, 10/17, 10/22
Extravascular administration Nornoo

Guest Lecturer: Drug-Drug Interactions in Drug Development. Dr Robert 10/24


Kumi, Clinical Pharmacology Reviewer, CDER, FDA
Exam II (20% of final grade) 10/31
Module Seven: Clearance Concepts: Renal 10/29, 11/05
Evang
Module Seven: Clearance Concepts: Hepatic 11/07, 11/19
Nornoo
Module Six: Bioavailability and Bioequivalence 11/12, 11/14
Miller
11/26, 12/03, 12/05
Module Eight: Volume of Distribution Nornoo
Exam III (20% of final grade) 11/28
Module Nine: Non-Linear Pharmacokinetics 12/10, 12/12
Nornoo
Final Exam (30% of final grade) 12/19
NB: The information contained in this course material is subject to change with prior
notification.

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