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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >When are bioavailability studies required? A German proposal.
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When are bioavailability studies required? A German proposal.

机译：什么时候需要进行生物利用度研究？德国的提案。

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摘要

The Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), the German drug regulation authority, issued guidelines for determining whether bioavailability/bioequivalence studies are required for certain drugs. This decision tree is based on pharmacodynamic, pharmacokinetic, and physicochemical criteria. Details of this decision tree were worked out by an expert panel, the Bioavailability Commission at the BfArM. The decision tree has been in use by German regulatory authorities for more than 10 years. In the meantime, its essentials were adopted by the European Committee for Proprietary Medicinal Products (CPMP) and by the World Health Organization (WHO) for their "Guidelines on interchangeability of multisource pharmaceutical products." This article reviews the original decision tree of the BfArM and provides examples of drugs that have been assessed according to its rules. The current procedure of the German regulatory authorities for judging the necessity of bioavailability trials, which reflects the status quo of regulatory practice in Germany, is also discussed.
机译：德国药品监管局（BundArstinstitut fur Arzneimittel und Medizinprodukte）发布了确定某些药物是否需要生物利用度/生物等效性研究的指南。该决策树基于药效学，药代动力学和理化指标。该决策树的详细信息由BfArM的生物利用度委员会专家小组制定。决策树已被德国监管机构使用了10多年。同时，欧洲专利药品委员会（CPMP）和世界卫生组织（WHO）采纳了其要点，以作为其“多源药品可互换性指南”。本文回顾了BfArM的原始决策树，并提供了根据其规则进行评估的药物示例。还讨论了德国监管机构目前用于评估生物利用度试验必要性的程序，该程序反映了德国监管实践的现状。

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