FDA Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry Draft

标准简介

Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry Draft[附网盘链接]由Food&Drug Administration于之前发布，适用于美国。

标准截图

 

标准文档说明

标准文档类型为Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry Draft[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Draft — Not for Implementation 1 Clinical Drug Interaction Studies With Combined Oral 2 Contraceptives 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 This guidance is intended to help sponsors of investigational new drug applications (INDs) and 18 new drug applications (NDAs) evaluate the need for drug-drug interaction (DDI) studies of their 19 investigational drugs with combined oral contraceptives (COCs), design such studies, and 20 determine how to communicate DDI study results and mitigation strategies to address potential 21 risks associated with increased or decreased exposure of COCs in labeling. This guidance 22 focuses on evaluating the DDI potential of an investigational drug (i.e., perpetrator) on a COC 23 (i.e., victim). 24 25 Reference is made to the FDA final guidances for industry entitled Clinical Drug Interaction 26 Studies – Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2

27 2020) for general principles in assessing the clinical DDI potential and In Vitro Drug 28 Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions 29 (January 2020) for in vitro experimental approaches to evaluate the interaction potential for 30 investigational drugs that involve metabolizing enzymes and/or transporters. This guidance 31 focuses solely on specific recommendations relevant to metabolism-based drug interactions with 32 COCs. Other mechanisms that can cause an interaction (e.g., absorption-based) are not 33 addressed in this guidance but should be considered by sponsors and investigators. In addition, 34 this guidance does not discuss DDIs with progestin-only pills (POPs) and contraceptives 35 administered via non-oral routes (e.g., transdermal systems). However, a DDI study with a COC 36 could inform the impact of other types of contraceptives containing the same progestin. 37 38 In general, the FDA’s guidance documents do not establish legally enforceable responsibilities. 39 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 40 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 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

We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

网盘链接

百度网盘：https://pan.baidu.com/s/1PH01o-rPBfO6FSyXHQmxtQ
提取码：g29y