Abstract：
The workshop \"Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS) Based Biowaivers\" was held virtually on December 6, 2021, organized by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), and the Food and Drug Administration (FDA). The workshop focused on the industrial, academic, and regulatory experiences in generating and evaluating permeability data, with the aim to further facilitate implementation of the BCS and efficient development of high-quality drug products globally. As the first international permeability workshop since the BCS based biowaivers was finalized as the ICH M9 guideline, the workshop included lectures, panel discussions, and breakout sessions. Lecture and panel discussion topics covered case studies at IND, NDA, and ANDA stages, typical deficiencies relating to permeability assessment supporting BCS biowaiver, types of evidence that are available to demonstrate high permeability, method suitability of a permeability assay, impact of excipients, importance of global acceptance of permeability methods, opportunities to expand the use of biowaivers (e.g. non-Caco-2 cell lines, totality-of-evidence approach to demonstrate high permeability) and future of permeability testing. Breakout sessions focused on 1) in vitro and in silico intestinal permeability methods; 2) potential excipient effects on permeability and; 3) use of label and literature data to designate permeability class.
摘要：
由马里兰大学监管科学与创新卓越中心（M-CERSI）组织的“药物渗透性-基于生物制药分类系统（BCS）的生物保护者的最佳实践”研讨会实际上于2021年12月6日举行，以及食品和药物管理局（FDA）。研讨会的重点是工业，学术,以及生成和评估渗透率数据的监管经验，旨在进一步促进BCS的实施和全球高质量药物产品的有效开发。作为第一个国际渗透研讨会，自BCS为基础的生物废弃物被定稿为ICHM9指南以来，研讨会包括讲座，小组讨论,和分组会议。讲座和小组讨论主题涵盖IND的案例研究，NDA,和ANDA阶段，与支持BCS生物保护的渗透率评估相关的典型缺陷，可用于证明高渗透性的证据类型，渗透性测定的方法适用性，辅料的影响，全球接受渗透方法的重要性，扩大生物保护者使用的机会(例如非Caco-2细胞系，证明高渗透率的总体证据方法)和渗透率测试的未来。分组讨论的重点是1）体外和电子肠通透性方法；2）潜在的赋形剂对通透性的影响；3）使用标签和文献数据来指定通透性等级。
