Wang Yaning, Bhattaram A Venkatesh, Jadhav Pravin R, Lesko Lawrence J, Madabushi Rajanikanth, Powell J Robert, Qiu Wei, Sun He, Yim Dong S, Zheng Jenny J, Gobburu Jogarao V S
Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993-0002, USA.
J Clin Pharmacol. 2008 Feb;48(2):146-56. doi: 10.1177/0091270007311111.
The End-of-Phase 2A meetings are proposed to identify opportunities to make innovative medical products available sooner and to increase the quality of drug applications through early meetings between sponsors and the FDA. This article summarizes the overall experience across 11 pilot End-of-Phase 2A meetings since 2004. Four case studies are presented in more detail to demonstrate the various issues and methods encountered at these meetings. Overall, industry and FDA scientists ranked these meetings to be "very helpful" (average score of 4 on a scale of 1 to 5). In almost all the instances the sponsors changed their drug development plans subsequent to these extensive quantitative analyses-based meetings. A draft Guidance is being developed to be issued in 2008, and we hope this initiative will be resourced by then.
提议召开2A期结束会议，以确定更快推出创新医疗产品的机会，并通过申办方与美国食品药品监督管理局（FDA）的早期会议提高药品申请质量。本文总结了自2004年以来11次2A期结束试点会议的总体经验。更详细地介绍了四个案例研究，以说明这些会议中遇到的各种问题和方法。总体而言，行业和FDA科学家将这些会议评为“非常有帮助”（在1至5分的评分中平均得分为4分）。在几乎所有情况下，申办方在这些基于广泛定量分析的会议之后都改变了他们的药物开发计划。正在制定一份指南草案，将于2008年发布，我们希望届时这项举措能获得资源支持。
