Zhang Xinyuan, Zheng Nan, Lionberger Robert A, Yu Lawrence X
Ther Deliv. 2013 Jun;4(6):725-40. doi: 10.4155/tde.13.41.
In this article, the authors will briefly introduce the general concepts and background of bioavailability and bioequivalence (BE), discuss the conventional method for BE demonstration, and present case examples where novel approaches have been adopted by the US FDA for BE demonstration. Here, 'novel approaches' include unconventional BE studies, as well as statistical criteria for comparison. More specifically, biowaivers, methods to demonstrate BE for highly variable drugs and drug products, and narrow therapeutic index drugs, partial AUCs as additional metrics for some modified-release drug products, methods to demonstrate BE for locally acting gastrointestinal, dermatological, nasal and inhalation products, and non-biological complex drug products, and future perspectives in the field of BE assessment will be discussed. Methods adopted by other agencies, such as European Medicines Agency and Health Canada will be compared with the FDA approaches when appropriate.
在本文中，作者将简要介绍生物利用度和生物等效性（BE）的一般概念和背景，讨论BE证明的传统方法，并列举美国食品药品监督管理局（FDA）采用新方法进行BE证明的案例。这里，“新方法”包括非常规BE研究以及比较的统计标准。更具体地说，将讨论生物豁免、高可变药物和药品、窄治疗指数药物的BE证明方法、部分AUC作为某些缓释药品的附加指标、局部作用的胃肠道、皮肤科、鼻腔和吸入产品以及非生物复杂药品的BE证明方法，以及BE评估领域的未来展望。适当时，将把欧洲药品管理局和加拿大卫生部等其他机构采用的方法与FDA的方法进行比较。
