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FDA Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions

蒋千琴 12/7/2021 浏览 173 FDA United States

标准简介

Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions[附网盘链接]是FDA于不久之前发布的FDA标准，适用于United States。

标准截图

Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions[附网盘链接]
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions[附网盘链接](截图)

 

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标准部分原文

Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This final guidance helps sponsors of investigational new drug applications and applicants of new drug applications evaluate drug-drug interactions (DDIs) during drug development and 2

determine essential information to communicate in labeling. This final guidance describes clinical studies to evaluate the DDI potential of an investigational drug, including: (1) the timing and design of the clinical studies; (2) the interpretation of the study results; and (3) the options for managing DDIs in patients. Specifically, this guidance provides considerations for evaluating pharmacokinetic cytochrome P450 (CYP) enzyme- or transporter-mediated interactions. A related final January 2020 FDA guidance for industry entitled In Vitro Drug Interaction 3

Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions focuses on how to assess the DDI potential of a drug in vitro and how to use the results from those assessments to inform clinical DDI studies. Together, these two final guidances on DDIs describe a systematic, risk-based approach for evaluating DDIs and determining essential information to communicate in labeling. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 1

This guidance has been prepared by the Office of Clinical Pharmacology, Office of Translational Sciences in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

This guidance does not discuss DDIs involving therapeutic proteins, protein displacement, modulation of Phase II metabolic enzymes, or other mechanisms that do not involve cytochrome P450 enzymes or transporters (e.g. gastric pH change, complexation). 3

We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

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