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Clinical drug interaction studies with combined oral contraceptives: guidance for industry
Clinical drug interaction studies with combined oral contraceptives: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Contraceptives, Oral
Drug Evaluation
Drug Industry
Drug Interactions
Government Regulation
United States - Genre(s):
- Guideline
Technical Report - Abstract:
- This guidance is intended to help sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs), design DDI studies, and determine how to communicate DDI study results and risk mitigation strategies in labeling to address potential risks associated with increased or decreased exposure of COCs. Reference is made to the FDA guidances entitled Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020) for general principles in assessing the clinical DDI potential and In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020) for in vitro experimental approaches to evaluate the interaction potential for investigational drugs that involve metabolizing enzymes and/or transporters. This guidance focuses solely on specific recommendations relevant to metabolism-based drug interactions with COCs. Other mechanisms that can cause an interaction (e.g., absorption-based) are not addressed in this guidance but should be considered by sponsors and investigators. In addition, this guidance does not discuss DDIs with progestin-only pills (POPs) and contraceptives administered via non-oral routes (e.g., transdermal systems). However, a DDI study with a COC could inform the impact on other types of contraceptives containing the same progestin. 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 as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (12 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918662583206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662583206676