Postmarketing surveillance: curriculum for the clinical pharmacologist. Part II: 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 and possible earlier marketing of drugs, this becomes an essential element of clinical pharmacology training. The usual educational focus on drug safety is a pharmacokinetic or pharmacodynamic perspective on a specific drug or drug class, perhaps in the context of clinical trial study design and analysis. This curriculum complements this approach and provides an overview of drug safety surveillance from regulatory and epidemiologic perspectives.
Johnson
J M
JM
Division of Epidemiology and Surveillance, Food and Drug Administration, Rockville, Maryland 20857.
Tanner
L A
LA
D016907:Adverse Drug Reaction Reporting Systems; D002986:Clinical Trials as Topic; D003479:Curriculum; D006801:Humans; D010601:Pharmacology, Clinical / Q000193:education*; D011358:Product Surveillance, Postmarketing; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration