Dissolution Testing for Generic Drugs: An FDA Perspective
Dissolution Testing for Generic Drugs: An FDA Perspective
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DOI：
10.1208/s12248-011-9272-y
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发表时间：
2011-09-01
期刊：
影响因子：
4.5
通讯作者：
Davit, Barbara M.
中科院分区：
文献类型：
--
作者：
Anand, Om;Yu, Lawrence X.;Davit, Barbara M.
体外溶出度测试是用于开发和批准仿制药剂型的重要工具。本文的目的是总结如何在美国 (US) 使用溶出度测试来批准安全有效的仿制药产品。溶出度测试通常用于口服和非口服剂型的稳定性和质量控制目的。应根据剂型使用适当的经过验证的方法来开发溶出方法。溶出度测试通过多种方式在监管决策中发挥关键作用。它可用于免除体内生物等效性 (BE) 研究要求，作为扩大规模和批准后变更 (SUPAC) 的 BE 文件，并预测改良释放 (MR) 药品与酒精饮料共同给药时剂量倾卸的可能性。因此，体外溶出测试在 FDA 努力减轻仿制药开发中的监管负担和不必要的人体研究而不牺牲药品质量的努力中发挥着重要作用。
In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modified-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Thus, in vitro dissolution testing plays a major role in FDA's efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products.