Drug Metabolism Drug Interaction Studies in the Drug Development Process Studies In Vitro Guidance 1998

This guidance is directed towards a broad class of drugs, namely molecules with a molecular weight below 10 kilo Daltons, and it provides suggestions on current approaches to in vitro studies of metabolism and interactions of such molecules. The guidance is intended to encourage routine, thorough evaluation of metabolism and interactions in vitro whenever feasible and appropriate. This guidance recognizes that the importance of such an approach will vary depending on the drug in development and its intended clinical use. It also recognizes that clinical observations can address some of the same issues identified in this document as being susceptible to in vitro study.

The guidance covers the following topics: observations and conclusions; techniques and approaches for in vitro studies for drug metabolism and drug-drug interactions (DDI); correlations between studies in vitro and in vivo; timing of metabolism studies; labeling; and related applications and considerations. This subject is discussed in detail in Chapter 6 of this book.

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