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作者： CHEN Mei-lin Center for Drug Evaluation and Research (CDER),Food and Drug Administration

Bioequivalence studies play an important role in the drug development as well as during the post-approval peri- od for both new drugs and generic *** principle,the goals of these studies are two-fold:(1)serve as bridging studies to provide supportive evidence for safety and effica- cy of a drug product;and(2)ensure product quality and performance throughout the life time of a drug product in the presence of changes in formulation or manufacturing. Additionally,in the context of generic drugs,the current *** dictates that evidence of bioequivalence and pharmaceutical equivalence provides the assurance of therapeutic equivalence,hence interchangeability. The conventional wisdom for bioequivalence studies indicates that the testing is best performed using the most accurate,sensitive,and reproducible approach available for the drug under ***,to date, comparative pharmacokinetic studies have been used in most cases for bioequivalence *** vitro tests are seldom utilized while pharmacodynamic studies and clinical trials are employed for locally acting drug products or when drug levels cannot be measured in the *** trend,however,is changing with the recent advances in pharmaceutical science and *** example,the introduction of the Biopharmaceutics Classification System (BCS)has provided a valuable tool for predicting drug ab- sorption and *** rapidly growing knowl- edge of pharmacogenetics/genomics combined with formu- lation science may facilitate a better understanding of the potential interplay between pharmaceutical characteristics and biological system in *** the future,an en- hanced prediction and assessment of bioequivalence may be achieved through the rational design of formulations and use of in vitro,in situ or in silico test methods. Implicit in the inclusion of pharmaceutical equiva- lence as part of the definition of therapeutic equivalence has been the regulatory objective

关键词： generic drug bioequivalence therapeutic equivalence Biopharmaceutics Classification System(BCS) in vitro in vivo

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Rethinking bioequivalence and equivalence requirements of orally inhaled drug products

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Asian Journal of Pharmaceutical Sciences 2015年第6期10卷 461-471页

作者： Dina Al-Numani Philippe Colucci Murray P.Ducharme Learn and Confirm Inc. St-LaurentQCCanada Facultéde Pharmacie University of MontrealMontrealQCCanada1

Orally inhaled drug products(OIPs),such as corticosteroids and bronchodilators,are at the forefront of asthma and chronic obstructive pulmonary disease treatments,two diseases that afflict worldwide *** generics of these products is essential,as the pricing of these medications remain a barrier to adequate patient ***,there is no consensus between regulatory bodies as to the bioequivalence and equivalence requirements of OIPs that are intended for local action in the *** manuscript critically reviews these requirements and presents future directions for clinicians,scientists,and regulators to consider to optimize the development and approval of OIPs.

关键词： Inhalation products Pharmacokinetics Pharmacodynamics Bioequivalence therapeutic equivalence Clinical endpoint studies

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