Polli James E, Abrahamsson Bertil S I, Yu Lawrence X, Amidon Gordon L, Baldoni John M, Cook Jack A, Fackler Paul, Hartauer Kerry, Johnston Gordon, Krill Steve L, Lipper Robert A, Malick Waseem A, Shah Vinod P, Sun Duxin, Winkle Helen N, Wu Yunhui, Zhang Hua
Univerisity of Maryland School of Pharmacy, Baltimore, MD, 21201, USA.
AAPS J. 2008 Jun;10(2):373-9. doi: 10.1208/s12248-008-9040-9. Epub 2008 Aug 5.
The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.
“生物等效性、生物药剂学分类系统及其他相关内容”研讨会于2007年5月21日至23日在美国马里兰州北贝塞斯达举行。本次研讨会为制药科学家提供了一个机会，以讨论美国食品药品监督管理局（FDA）关于生物药剂学分类系统（BCS）、口服产品生物等效性以及相关FDA举措（如FDA关键路径计划）的指南。本研讨会总结报告的目的是记录本次研讨会的要点。研讨会的主要亮点包括：（a）FDA批准了十几种基于BCS的生物豁免，用于其制剂表现出快速溶解的I类药物；（b）对制剂表现出非常快速溶解的III类化合物的生物豁免持续提供科学支持；（c）对多种评估BCS渗透性类别的渗透性方法提供科学支持；（d）BCS在药物研发中的应用；以及（e）体外溶出方法在预测剂型性能方面的科学进展。
