It is widely believed that acceptable bioequivalence studies of drugs with high within-subject pharmacokinetic variability must enroll higher numbers of subjects than studies of drugs with lower variability. We studied the scope of this issue within US generic drug regulatory submissions.
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, 7520 Standish Place, Rockville, Maryland 20855, USA. barbara.davit@fda.hhs.gov
