Guidance for Industry. In Vivo Drug Metabolism/Drug Interaction Studies: Study Design, Data Analysis, and Recommendations for Dosing and Labeling

摘要

This guidance provides recommendations to sponsors of new drug applications (NDAs) and biologics license applications (BLAs) for therapeutic biologics (hereafter drugs) who intend to perform in vivo drug metabolism and metabolic drug-drug interaction studies. The guidance reflects the Agencys current view that the metabolism of an investigational new drug should be defined during drug development and that its interactions with other drugs should be explored as part of an adequate assessment of its safety and effectiveness. For metabolic drug-drug interactions, the approaches considered in the guidance are offered with the understanding that whether a particular study should be performed will vary, depending on the drug in development and its intended clinical use. Furthermore, not every drug-drug interaction is metabolism-based, but may arise from changes in pharmacokinetics caused by absorption, tissue and/or plasma binding, distribution, and excretion interactions. Drug interactions related to transporters are being documented with increasing frequency and may be addressed more fully in future guidances.