Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report
Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report
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DOI：
10.1208/s12248-011-9294-5
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发表时间：
2011-12-01
期刊：
影响因子：
4.5
通讯作者：
Yu, Lawrence X.
中科院分区：
文献类型：
--
作者：
Chen, Mei-Ling;Shah, Vinod P.;Yu, Lawrence X.
不同国家和/或地区评价多药（或仿制药）药品治疗等效性的监管方法各不相同。这些方法的协调可能会减少体内生物等效性研究的数量，并避免不必要的药物暴露于人体。通过更好地了解产品性能的基本因素和不同监管机构的期望，可以促进监管要求的全球统一。该研讨会为来自学术界、工业界和监管机构的制药科学家提供了一个机会，就当前的监管问题和行业实践进行公开讨论，促进监管方法的协调，以确定多药制剂的治疗等效性和可重复性。
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.