This guidance provides recommendations to sponsors of NDAs and biologies license applications (BLAs) for therapeutic biologies (hereafter drugs) who intend to perform in vivo drug metabolism and metabolic drug-drug interaction studies. The guidance reflects the Agency's 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 PK caused by absorption, tissue, and/or plasma binding, distribution and excretion interactions. Drug interactions related to transporters or pharmacodynamic-based drug interactions are not covered in this guidance.
After a brief discussion on metabolism and metabolic DDIs, the guidance covers the following topics: general strategies; design of in vivo metabolic drug-drug interaction studies; and labeling.
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