highly variable drugs- foodand drug administration（drugs- highly variable foodand drug administration）.docVIP

Background Information for Advisory Committee Meeting On April 14, 2004 Bioequivalence Requirements for Highly Variable Drugs and Drug Products Introduction Bioequivalence studies are generally conducted by comparing the in vivo rate and extent of drug absorption of a test and a reference drug product in healthy subjects. In a standard in vivo bioequivalence study design, participants receive a single dose of test and reference products on separate occasions with random assignment to the two possible sequences of product administration. Samples of an accessible biologic fluid such a