649 CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
Clinical pharmacology plays a critical role in drug development - in part by evidence of the “Clinical Pharmacology” section in the labeling of drugs in the US. Clinical pharmacology is a translational discipline that informs the how drugs can best be used. This course is designed to orient students to several types of clinical pharmacology studies in drug development, as well as their underlying principles. Studies include: first-in-human studies; food effect studies; bioavailability studies; bioequivalence studies; drug-drug interaction studies (e.g. enzyme-based inhibition and induction studies, as well as transporter-based studies); and effect of hepatic or renal impairment studies. Variables such as age (e.g. pediatric and geriatric) and race/ethnicity (e.g. ICH E5 ethnic factors in the acceptability of foreign clinical data) are also featured.
Standard Grade Mode