建立模型整合证据用于证明长效注射和植入药物产品生物等效性的适宜性：研讨会总结。
Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop.
机构信息
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
出版信息
CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):624-630. doi: 10.1002/psp4.12931. Epub 2023 Feb 9.
On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled "Establishing the Suitability of Model-Integrated Evidence (MIE) to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable (LAI) Drug Products." This workshop brought relevant parties from the industry, academia, and the FDA in the field of modeling and simulation to explore, identify, and recommend best practices on utilizing MIE for bioequivalence (BE) assessment of LAI products. This report summerized presentations and panel discussions for topics including challenges and opportunities in development and assessment of generic LAI products, current status of utilizing MIE, recent research progress of utilizing MIE in generic LAI products, alternative designs for BE studies of LAI products, and model validation/verification strategies associated with different types of MIE approaches.
2021 年 11 月 30 日，美国食品和药物管理局（FDA）和复杂仿制药研究中心（CRCG）举办了一场名为“确立模型整合证据（MIE）用于证明长效注射和植入（LAI）药物产品生物等效性的适宜性”的虚拟公开研讨会。此次研讨会召集了来自工业界、学术界和 FDA 的相关各方，共同探讨、确定和推荐利用 MIE 进行 LAI 产品生物等效性（BE）评估的最佳实践。本报告总结了专题演讲和小组讨论的内容，涉及通用 LAI 产品开发和评估的挑战和机遇、利用 MIE 的现状、利用 MIE 进行通用 LAI 产品研究的最新进展、LAI 产品 BE 研究的替代设计，以及与不同类型 MIE 方法相关的模型验证/验证策略。
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