推进仿制药开发：以患者为中心的口服制剂的生物等效性挑战——2026年6月11日
正文 · 中文译文
网络研讨会 | 虚拟 活动名称 推进仿制药开发：以患者为中心的口服制剂的生物等效性挑战 2026年6月11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……你需要了解的事项 日期： 2026年6月11日 访问CDER小企业与行业援助（SBIA）主页 主题与报告 演讲者 第一场 仿制药开发中以患者为中心的制剂现状 录像和幻灯片 Karen Li，药学博士 药理学专家 治疗性能二部（DTP II） 研究与标准办公室（ORS） 仿制药办公室（OGD）| CDER 开发儿科制剂：监管考量 录像和幻灯片 Vilayat Sayeed，博士 部门主任 产品质量评估二部 产品质量评估办公室一（OPQA I） 药品质量办公室（OPQ）| CDER 适用性请愿：以患者为中心制剂的途径 录像和幻灯片 Andrew Fine，药学博士 监管事务副主任 安全与临床评估办公室 OGD | CDER 利用PBPK建模进行外推以支持儿科产品开发 录像和幻灯片 Fang Wu，博士 高级药理学专家 定量方法与建模部 ORS | OGD | CDER 第一场问答环节 录像 主持人 Jihong Shon，医学博士、博士 临床安全副主任 DTP II | ORS | OGD | CDER 讨论嘉宾 Karen Li Vilayat Sayeed Andrew Fine Fang Wu 以及特邀加入 Meirong Hao，博士 首席药理学家 生物等效性三处 生物等效性办公室（OB）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 第二场 咀嚼片生物等效性策略：监管考量 录像和幻灯片 Hye Lim Lim，药学博士 访问学者 药物技术二处（DTP II）| 研究标准办公室（ORS）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 颗粒剂和微丸产品特定指南（PSGs） 录像和幻灯片 Wen Cheng Yang，医学博士 高级研究员 药物技术二处（DTP II）| 研究标准办公室（ORS）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 口服混悬液产品药代动力学生物等效性研究的剂量选择考量 录像和幻灯片 Duyen Nguyen，药学博士 研究员 药物技术二处（DTP II）| 研究标准办公室（ORS）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 舌下产品的科学和监管考量 录像和幻灯片 Wei-Jhe Sun，博士 高级研究员 药物技术二处（DTP II）| 研究标准办公室（ORS）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 口腔崩解片生物等效性策略：监管考量 录像和幻灯片 Heather Boyce，博士 首席药代动力学专家 药物技术二处（DTP II）| 研究标准办公室（ORS）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 体外喂养管研究：科学和监管视角 录像和幻灯片 Geng Tian，博士 研究主管 药物质量研究六处 药物质量研究办公室 药品质量办公室（OPQ）| 药物评价与研究中心（CDER） Shamema Nasrin，博士 研究科学家 药物技术二处（DTP II）| 研究标准办公室（ORS）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 第二场问答环节 录像 主持人 Jihong Shon 讨论嘉宾 Hye Lim Lim Wen Cheng Yang Duyen Nguyen Wei-Jhe Sun Heather Boyce Shamema Nasrin Geng Tian 以及特邀加入 Xiaojian Jiang，博士 副处长 生物等效性二处 生物等效性办公室（OB）| 仿制药办公室（OGD）| 药物评价与研究中心（CDER） 闭幕致辞 录制 Myong-Jin Kim，药学博士 部门主任 DTP II | ORS | OGD | CDER 关于本次活动（由CDER SBIA主办） 患者专用口服药物制剂领域持续发展，呈现出独特的生物等效性（BE）挑战，需要创新的监管方法。本次研讨会旨在促进关于以患者为中心（包括儿科）的仿制口服产品不断演变领域的最新进展和监管考虑的讨论，探讨这些重要药物在产品开发和监管评估方面的挑战。 参会者将深入了解在多个领域开发专用口服制剂仿制版本中的复杂问题。讨论范围将包括咀嚼片、口崩片、微丸/颗粒制剂、混悬剂产品以及舌下/颊部制剂。本次研讨会还将讨论为满足吞咽困难患者群体独特需求而设计的儿科专用仿制制剂的开发和评估挑战。 通过一系列由专家主导的报告和问答环节，参与者将有机会听取FDA专家的意见并向其提问，以帮助加深对当前最佳实践、挑战与机遇、监管期望以及新兴趋势的理解。具体而言，研讨会将涵盖关键领域，如以患者为中心的制剂的监管策略、制剂特定的开发问题、儿科制剂的监管策略，以及包括基于生理的药代动力学（PBPK）建模在内的创新生物等效性（BE）方法，以支持仿制儿科产品开发。这些主题反映了以患者为中心的口服仿制药开发所面临的一些最具挑战性的问题，研讨会将促进对为克服这些挑战而采用的科学和监管创新的讨论。 不要错过这个了解如何改进您的仿制药开发的独特机会！ 目标受众 从事或有兴趣从事口服仿制药开发的科学家、研究人员、当前和潜在的仿制药申请人以及法规事务专业人员。 涵盖主题 以患者为中心的口服制剂的常见监管挑战 支持各种以患者为中心的口服制剂（包括咀嚼片、微丸/颗粒剂、舌下/颊膜制剂、口崩片和混悬剂）产品开发和生物等效性（BE）评价（包括喂食管研究和BE研究剂量选择）的最新制剂特异性监管策略和最佳实践。 仿制口服儿科制剂开发的已知问题和实用策略 学习目标 了解与相关口服仿制药产品有关的科学、研究、FDA指南建议和监管视角的最新进展 认识并解释如何利用FDA的GDUFA资助研究来支持和指导仿制药开发 学习如何利用各种策略和方法来促进高效的仿制药开发 资源 GDUFA科学与研究 仿制药开发 GDUFA III重新授权 Pre-ANDA计划 仿制药开发产品特异性指南 与仿制药相关的指南（在主题下，选择“generic drugs”） 内容截至日期： 11/03/2026 受监管产品 药品 仿制药
正文 · 英文原文
Webcast | Virtual Event Title Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations June 11, 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: June 11, 2026 Visit CDER Small Business and Industry Assistance (SBIA) Homepage Topics & Presentations Speakers Session 1 Current Landscape of Patient-Centric Formulations in Generic Drug Development Recording and Slides Karen Li, PharmD Pharmacologist Division of Therapeutic Performance II (DTP II) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) | CDER Developing Pediatric Formulations: Regulatory Considerations Recording and Slides Vilayat Sayeed, PhD Division Director Division of Product Quality Assessment II Office of Product Quality Assessment I (OPQA I) Office of Pharmaceutical Quality (OPQ) | CDER Suitability Petitions: An Avenue for Patient-Centric Formulations Recording and Slides Andrew Fine, PharmD Associate Director for Regulatory Affairs Office of Safety and Clinical Evaluation OGD | CDER Extrapolation Using PBPK Modeling to Support the Development of Pediatric Products Recording and Slides Fang Wu, PhD Senior Pharmacologist Division of Quantitative Methods and Modeling ORS | OGD | CDER Questions and Answer Session 1 Recording Moderator Jihong Shon, MD, PhD Associate Director for Clinical Safety DTP II | ORS | OGD | CDER Panelists Karen Li Vilayat Sayeed Andrew Fine Fang Wu and joined by Meirong Hao, PhD Lead Pharmacologist Division of Bioequivalence III Office of Bioequivalence (OB) | OGD | CDER Session 2 Bioequivalence Strategies for Chewable Tablets: Regulatory Considerations Recording and Slides Hye Lim Lim, PharmD Visiting Associate DTP II | ORS | OGD | CDER Granules and Pellets PSGs Recording and Slides Wen Cheng Yang, MD Senior Staff Fellow DTP II | ORS | OGD | CDER Dose Selection Consideration for Pharmacokinetic Bioequivalence Studies of Oral Suspension Products Recording and Slides Duyen Nguyen, PharmD Staff Fellow DTP II | ORS | OGD | CDER Scientific and Regulatory Considerations for Sublingual Products Recording and Slides Wei-Jhe Sun, PhD Senior Staff Fellow DTP II | ORS | OGD | CDER Bioequivalence Strategies for Orally Disintegrating Tablets: Regulatory Considerations Recording and Slides Heather Boyce, PhD Lead Pharmacokineticist DTP II | ORS | OGD | CDER In Vitro Feeding Tube Studies: Scientific and Regulatory Perspectives Recording and Slides Geng Tian, PhD Research Officer Division of Pharmaceutical Quality Research VI Office of Pharmaceutical Quality Research OPQ | CDER Shamema Nasrin, PhD Research Scientist DTP II | ORS | OGD | CDER Questions and Answer Session 2 Recording Moderator Jihong Shon Panelists Hye Lim Lim Wen Cheng Yang Duyen Nguyen Wei-Jhe Sun Heather Boyce Shamema Nasrin Geng Tian and joined by Xiaojian Jiang, PhD Deputy Division Director Division of Bioequivalence II OB | OGD | CDER Closing Remarks Recording Myong-Jin Kim, PharmD Division Director DTP II | ORS | OGD | CDER About this Event (Hosted by CDER SBIA) The field of patient-specialized oral drug formulations continues to evolve, presenting unique bioequivalence (BE) challenges that require innovative regulatory approaches. This workshop is designed to facilitate discussions about the latest advancements and regulatory considerations in the evolving field of patient-centric (including pediatric) generic oral products, addressing product development and regulatory assessment challenges for these important medicines. Attendees will gain valuable insights into the intricacies of developing generic versions of specialized oral formulations across diverse areas. The scope of discussions will include chewable tablets, orally disintegrating tablets, pellet/granule formulations, suspension products, and sublingual/buccal formulations. This workshop will also address challenges for the development and assessment of generic pediatric-specific formulations designed to meet the unique needs of patient populations with swallowability challenges. Through a series of expert-led presentations and Q&A sessions, participants will have the opportunity to hear from and pose questions to experts from FDA, to help deepen their understanding of current best practices, challenges and opportunities, regulatory expectations, and emerging trends. Specifically, the workshop will cover critical areas such as regulatory strategies for patient-centric formulations, formulation-specific development issues, regulatory strategies for pediatric formulations, and innovative BE approaches including physiologically based pharmacokinetic (PBPK) modeling to support generic pediatric product development. These topics reflect some of the most challenging issues facing patient-centric oral generic drug development, and the workshop will facilitate a discussion of the scientific and regulatory innovations being deployed to overcome these challenges. Don't miss this unique opportunity to learn how to improve your generic drug development! Intended Audience Scientists, researchers, current and prospective generic drug applicants, and regulatory affairs professionals who work on or have an interest in the development of oral generic drugs. Topics Covered Common regulatory challenges of patient-centric oral formulations Up-to-date formulation-specific regulatory strategies and best practices to support the product development and BE evaluation (including feeding tube studies and BE study dose selection) of various patient-centric oral formulations, including chewable tablets, pellets/granules, sublingual/buccal products, orally disintegrating tablets, and suspensions. Known issues and practical strategies for the development of generic oral pediatric formulations Learning Objectives Stay up to date with the latest advancements in science, research, FDA guidance recommendations, and regulatory perspectives related to relevant oral generic drug products Recognize and explain how the FDA's GDUFA-funded research can be leveraged to support and inform generic drug development Learn how to utilize various strategies and methodologies to facilitate efficient generic drug development 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: 11/03/2026 Regulated Product(s) Drugs Generic Drugs