FDA发布药品相互作用研究、设计、数据分析指南草案

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FDA Announced Draft Guidance for Industry ‘Drug Interaction Studies - Study Design, Data Analysis, Implications For Dosing, And Labelling Recommendations

In the Federal Register of February 21, 2012, FDA announced the availability of a draft guidance for industry entitled ‘‘Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations” for comment.  This revised draft guidance provides recommendations for sponsors of NDAs and BLAs regarding in vitro and in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein interactions.  Namely, the guidance describes in vitro study methodologies, criteria for in vivo studies, in vivo study design, and data analysis in the context of identifying potential drug interactions.  The guidance also addresses the implications of drug interactions for dosing and labeling.

·       Background:  In September 2006, FDA published a draft guidance entitled “Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling.”  The FDA is now publishing a revised draft version to collect additional public comments.  The revised draft guidance includes discussion of several major changes, including the following: (1) When transporter-mediated drug interaction information is needed (including decision-trees); (2) drug-therapeutic protein interactions, (3) the utility of pharmacogenetic data; and (4) the use of physiologically based pharmacokinetic modeling.

Links to the revised draft guidance and its corresponding Federal Register notice are provided below.

·       Revised Draft Guidance

·       Federal Register Notice

kingphage

非常感谢。。

情非得已

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清风化雨

谢绝分享....

leilei050930

学习学习。