Determination of in vivo bioequivalence.
The May and June 2001 issues of Pharmaceutical Research contained three articles related to the determination of in vivo Bioequivalence. The articles discussed: (a) the bioequivalence of highly variable drugs, (b) novel metrics for direct comparison of bioequivalence study plasma curves, and (c) the role of a microemulsion vehicle on cutaneous bioequivalence. An analysis of the relationship and potential impact of these articles on their respective areas of bioequivalence will be addressed in this commentary.
Jackson
Andre J
AJ
Office of Generic Drugs, CDER, Division of Bioequivalence, FDA, Rockville, Maryland, USA. Jacksonan@CDER.FDA.Gov
D000818:Animals; D004337:Drug Carriers / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004341:Drug Evaluation / Q000379:methods; D004655:Emulsions; D006801:Humans; D013810:Therapeutic Equivalency
D004337:Drug Carriers; D004655:Emulsions