藥品銜接性試驗評估20周年國際研討會-International Conference on the 20th Anniversary of Bridging Study Evaluation скачать в хорошем качестве

藥品銜接性試驗評估20周年國際研討會-International Conference on the 20th Anniversary of Bridging Study Evaluation

00:00:00 01.Opening Remarks 00:22:24 02.20th Anniversary of ICH E5 Bridging Study – Reflection and Future Perspective 00:48:16 03.Policies for ICH E5 and E17 Implementation 01:13:50 04.PMDA’s perspectives on the implementation of ICH E5 01:39:05 05.Critical Visibility: CDE and Its Encounter with Regulatory World 02:06:30 06.Panel Discussion 02:33:07 07.An Overview of Logistics and Analyses of Bridging Study Evaluation Applications 02:59:12 08.Pharmacokinetic Considerations of Bridging Study Evaluation and Cases Studies – Regulatory Perspectives 03:34:00 09.Clinical Considerations of Bridging Study Evaluation and Cases Studies – Regulatory Perspectives 04:10:18 10.Implementation and Considerations of ICH E5 in Asian Regions – Global Pharmaceutical Industry Perspectives 04:25:55 11.Implementation and Considerations of ICH E5 in Asian Regions – Research-based Pharmaceutical Industry Perspectives 04:45:14 12.Panel Discussion