POSTMARKETING SURVEILLANCE - CURRICULUM FOR THE CLINICAL PHARMACOLOGIST .2. CLINICAL AND REGULATORY CONSIDERATIONS

This is the second of a two-part series that develops a curriculum on postmarketing surveillance. With the ongoing emphasis on drug safety a nd possible earlier marketing of drugs, this becomes an essential elem ent of clinical pharmacology training. The usual educational focus on drug safety is a pharmacokinetic or pharmacodynamic perspective on a s pecific drug or drug class, perhaps in the context of clinical trial s tudy design and analysis. This curriculum complements this approach an d provides an overview of drug safety surveillance from regulatory and epidemiologic perspectives.