推进仿制药开发：局部外用与透皮制剂的生物等效性方法现代化——2026年9月10日
正文 · 中文译文
研讨会 | 线上 活动名称 推进仿制药开发：现代化外用及透皮产品的生物等效性方法 2026年9月10日 更多会议、 大会和 研讨会 人用药品新闻与活动 会议、大会和研讨会 重要批准 CDER对话 我们的视角 CDER科学聚焦 关于……须知 日期： 2026年9月10日 时间： 上午8：30 - 下午12：40（美国东部时间） 议程 访问CDER小企业与行业援助（SBIA）主页 主题与报告 讲者 推进仿制药开发： 现代化外用及透皮产品的生物等效性方法 第1场 网络研讨会介绍与范围 录像 Priyanka Ghosh，博士 首席药理学家 治疗性能一部（DTP I） 研究与标准办公室（ORS） 仿制药办公室（OGD）| CDER 外用产品的当前建议与ANDA概况 录像和幻灯片 Tannaz Ramezanli，药学博士，博士 高级药理学家 DTP I | ORS | OGD | CDER IVPT研究的ANDA审评挑战——生物等效性视角 录像和幻灯片 Allison Schafer，博士 高级跨学科科学家 生物等效性二部（DBII） 生物等效性办公室（OB） OGD | CDER 支持他扎罗汀乳膏仿制药批准的机制建模 录像和幻灯片 Eleftheria Tsakalozou，博士 首席药理学家 定量方法与建模部（DQMM）ORS | OGD | CDER 第1场问答环节 录像 主持人： Priyanka Ghosh 专题讨论成员： Tannaz Ramezanli Allison Schafer Eleftheria Tsakalozou 以及以下人员加入： Robert Lionberger，博士 主任 ORS | OGD | CDER Partha Roy，博士 主任 OB | OGD | CDER William Chong，医学博士 主任 安全与临床评估办公室（OSCE） OGD | CDER Pahala Simamora，博士 主任 产品质量评估九部（DPQA IX） 产品质量评估二办公室（OPQA II） 药品质量办公室（OPQ） | CDER 推进仿制药开发： 现代化局部及透皮产品的生物等效性方法 第二场会议 局部泡沫制剂的关键处方、泡沫结构及性能属性 录像和幻灯片 Ahmed Zidan，博士 高级研究药理学家 产品质量与研究五部（DPQR V） 药品质量研究办公室（OPQR） OPQ | CDER 体外渗透试验（IVPT）揭秘：局部渗透方法开发中的挑战与解决方案 录像和幻灯片 Nahid Kamal，博士 药理学家 DPQR V | OPQR | OPQ | CDER 机制建模以简化特定产品指南（PSG）建议并减轻监管负担 录像和幻灯片 Eleftheria Tsakalozou，博士 首席药理学家 DQMM | ORS | OGD | CDER 第二场问答环节 录像 主持人： Hiren Patel，博士 高级研究员 DBII | OB | OGD | CDER 讨论组成员： Ahmed Zidan Nahid Kamal Eleftheria Tsakalozou 以及以下人员加入： Sam Raney，博士 科学副主任兼首席科学顾问 ORS | OGD | CDER Xiaoming Xu，博士 主任 DPQR V | OPQR | OPQ | CDER Andrew Babiskin，博士 副主任 DQMM | ORS | OGD | CDER 推进仿制药开发： 现代化局部与外用制品的生物等效性方法 第3场会议 透皮递送系统（TDS）的当前建议与ANDA格局 录像与幻灯片 Ying Jiang，博士 化学家 DTP I | ORS | OGD | CDER 第3场问答环节 录像 主持人： Megan Kelchen，博士 高级药理学家 DTP I | ORS | OGD | CDER 专题讨论成员： Ying Jiang Priyanka Ghosh 以及加入的： Markham C. Luke，医学博士，博士 主任 DTP I | ORS | OGD | CDER Robert Berendt，博士 监督型药物科学家 产品质量评估五部（DPQA V）产品质量评估办公室一（OPQA I） OPQ | CDER Wanjie Sun，博士 首席数理统计师 生物统计学八部（DB VIII） 生物统计学办公室（OB） 转化科学办公室（OTS）| CDER Ying Fan，博士 首席药理学家 临床审评部（DCR） OSCE | OGD | CDER 闭幕致辞 录像 Robert Lionberger 关于本次活动（由CDER SBIA主办） 本次为期半天的虚拟研讨会包括FDA专家报告和观众问答，内容涉及局部和外用仿制药品的生物等效性（BE）方法。 FDA利用仿制药使用者付费修正案（GDUFA）资助的监管科学与研究来制定和修订通用及产品特定指南，并支持简略新药申请（ANDA）审评。案例将展示研究结果如何为指南建议和ANDA评估提供依据。 参会者将获得关于当前FDA生物等效性（BE）建议、使用建模与模拟的替代方法、基于表征的申报资料，以及如何确定局部和外用递送系统何时可能需要体内研究的实用见解。 目标受众 科学家、研究人员、当前和潜在的仿制药申请人、法规事务专业人员，以及从事或有兴趣从事局部和外用仿制药产品开发的其他人员。 涵盖主题 局部产品的当前建议、实施挑战和替代BE方法。 案例示例展示GDUFA资助的研究如何为指南修订提供信息、减少申报缺陷并支持ANDA评估。 经验和计算机模拟研究如何支持产品特定指南和基于表征的BE方法，包括稳健的体外渗透试验（IVPT）方法开发。 局部和外用递送系统的建议和实施策略，包括如何确定何时需要诸如致敏研究等体内研究。 学习目标 了解FDA关于局部和外用仿制药产品的科学、指南建议和监管视角的最新进展。 理解GDUFA资助的研究如何为通用和产品特定指南及ANDA审评提供信息。 识别可支持这些复杂仿制药高效开发并减少可避免生物等效性缺陷的策略和方法。 FDA资源 GDUFA科学与研究 仿制药开发 GDUFA III重新授权 Pre-ANDA计划 仿制药开发产品特定指南 与仿制药相关的指南（在“主题”下选择“仿制药”） 内容截至日期： 2026年11月4日 受监管产品 药品 仿制药
正文 · 英文原文
Workshop | Virtual Event Title Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products September 10, 2026 More Meetings, Conferences, and Workshops News & Events for Human Drugs Meetings, Conferences, & Workshops Notable Approvals CDER Conversations From Our Perspective Spotlight on CDER Science Things to Know About... Date: September 10, 2026 Time: 8:30 a.m. - 12:40 p.m. ET Agenda Visit CDER Small Business and Industry Assistance (SBIA) Homepage Topics & Presentations Speakers Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products Session 1 Introduction and Scope of Webinar Recording Priyanka Ghosh, PhD Master Pharmacologist Division of Therapeutic Performance I (DTP I) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) | CDER Current Recommendations and ANDA Landscape for Topical Products Recording and Slides Tannaz Ramezanli, PharmD, PhD Senior Pharmacologist DTP I | ORS | OGD | CDER ANDA Assessment Challenges for IVPT Studies – Bioequivalence Perspective Recording and Slides Allison Schafer, PhD Senior Interdisciplinary Scientist Division of Bioequivalence II (DBII) Office of Bioequivalence (OB) OGD | CDER Mechanistic Modeling to Support the Approval of Generic Tazarotene Cream Recording and Slides Eleftheria Tsakalozou, PhD Lead Pharmacologist Division of Quantitative Methods and Modeling (DQMM) ORS | OGD | CDER Questions and Answer Session 1 Recording Moderator: Priyanka Ghosh Panelists: Tannaz Ramezanli Allison Schafer Eleftheria Tsakalozou and joined by: Robert Lionberger, PhD Director ORS | OGD | CDER Partha Roy, PhD Director OB | OGD | CDER William Chong, MD Director Office of Safety and Clinical Evaluation (OSCE) OGD | CDER Pahala Simamora, PhD Director Division of Product Quality Assessment IX (DPQA IX) Office of Product Quality Assessment II (OPQA II) Office of Pharmaceutical Quality (OPQ) | CDER Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products Session 2 Critical Formulation, Foam-Structure, and Performance Attributes of Topical Foams Recording and Slides Ahmed Zidan, PhD Senior Research Pharmacologist Division of Product Quality and Research V (DPQR V) Office of Pharmaceutical Quality Research (OPQR) OPQ | CDER IVPT Unplugged: From Challenges to Solutions in Topical Permeation Method Development Recording and Slides Nahid Kamal, PhD Pharmacologist DPQR V | OPQR | OPQ | CDER Mechanistic Modelling to Streamline PSG Recommendations and Reduce Regulatory Burden Recording and Slides Eleftheria Tsakalozou, PhD Lead Pharmacologist DQMM | ORS | OGD | CDER Question and Answer Session 2 Recording Moderator: Hiren Patel, PhD Senior Staff Fellow DBII | OB | OGD | CDER Panelists: Ahmed Zidan Nahid Kamal Eleftheria Tsakalozou and joined by: Sam Raney, PhD Associate Director for Science and Chief Scientific Advisor ORS | OGD | CDER Xiaoming Xu, PhD Director DPQR V | OPQR | OPQ | CDER Andrew Babiskin, PhD Deputy Director DQMM | ORS | OGD | CDER Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products Session 3 Current Recommendations and ANDA Landscape for TDS Recording and Slides Ying Jiang, PhD Chemist DTP I | ORS | OGD | CDER Question and Answer Session 3 Recording Moderator: Megan Kelchen, PhD Senior Pharmacologist DTP I | ORS | OGD | CDER Panelists: Ying Jiang Priyanka Ghosh and joined by: Markham C. Luke, MD, PhD Director DTP I | ORS | OGD | CDER Robert Berendt, PhD Supervisory Pharmaceutical Scientist Division of Product Quality Assessment V (DPQA V) Office of Product Quality Assessment I (OPQA I) OPQ | CDER Wanjie Sun, PhD Master Mathematical Statistician Division of Biometrics VIII (DB VIII) Office of Biostatistics (OB) Office of Translational Sciences (OTS) | CDER Ying Fan, PhD Lead Pharmacologist Division of Clinical Review (DCR) OSCE | OGD | CDER Closing Remarks Recording Robert Lionberger About this Event (Hosted by CDER SBIA) This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products. FDA uses Generic Drug User Fee Amendments (GDUFA)-funded regulatory science and research to develop and revise general and product-specific guidances and to support abbreviated new drug application (ANDA) review. Case examples will show how research findings have informed guidance recommendations and ANDA assessment. Attendees will gain practical insights into current FDA BE recommendations, alternative approaches that use modeling and simulation, characterization-based submissions, and how to determine when in vivo studies may be needed for topical and transdermal delivery systems. Intended Audience Scientists, researchers, current and prospective generic drug applicants, regulatory affairs professionals, and others who work on or have an interest in the development of topical and transdermal generic drug products. Topics Covered Current recommendations, implementation challenges, and alternative BE approaches for topical products. Case examples showing how GDUFA-funded research has informed guidance revisions, reduced submission deficiencies, and supported ANDA assessments. How empirical and in silico research supports product-specific guidances and characterization-based BE approaches, including robust in vitro permeation testing (IVPT) method development. Recommendations and implementation strategies for topical and transdermal delivery systems, including how to determine when in vivo studies such as sensitization studies are needed. Learning Objectives Stay up to date on FDA science, guidance recommendations, and regulatory perspectives for topical and transdermal generic drug products. Understand how GDUFA-funded research informs general and product-specific guidances and ANDA review. Identify strategies and methods that can support efficient development of these complex generics and reduce avoidable bioequivalence deficiencies. FDA Resources GDUFA Science and Research Generic Drug Development GDUFA III Reauthorization Pre-ANDA Program Product-Specific Guidances for Generic Drug Development Guidances Related to Generic Drugs (under Topics, choose "generic drugs") Content current as of: 11/04/2026 Regulated Product(s) Drugs Generic Drugs