Beruflich Dokumente
Kultur Dokumente
PHARMA TRANS 1.01 | Trans Team: Mindalano, Sangkula, Tero | Editor: Enriquez 1 of 2
Assessment of drug properties
(ADMET)
In Vitro Trials (cellular models)
In Vivo Trials (animal models or
human subjects)
Submission of Investigational New
Drug (IND)
Duration: 1-3 years (ave. 18 mo.)
III. Clinical development
Phase I: Dose-Toxicity and drug safety
and kinetics
Phase II: Drug efficacy and testing drug
combinations
Phase III: Drug comparison with
standard-of-care drug or placebo
(confirmatory clinical trial)
Duration: 2-10 years (ave. 5 years)
Submission of New Drug Application
(NDA)/Biologics License Application (BLA)
IV. Phase IV
Pharmacovigilance
Monitoring long-lasting side effects
1.
2. Advantage of generic it is cheaper
II. REFERENCES
Dr Diaz PPT