Guidance for Industry on In Vivo Drug Metabolism/Drug Interaction StudiesStudy Design, Data Analysis, and Recommendations for Dosing and Labeling; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``In Vivo Drug Metabolism/Drug Interaction Studies--Study Design, Data Analysis, and Recommendations for Dosing and Labeling.'' This guidance provides recommendations to sponsors of new drug applications (NDA's) and biologics license applications (BLA's) for therapeutic biologics on carrying out in vivo drug metabolism and metabolic drug-drug interaction studies. The guidance reflects the agency's current view that the metabolism of a 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 the safety and effectiveness of the drug.