PI-2

AIMS Creation of a concept paper that reflects the Agency's current view that the metabolism of a new drug should be adequately characterized and its potential to interact with other drugs should be explored as part of the assessment of safety and effectiveness. METHODS Latest scientific consen...

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Bibliographic Details
Published in:	Clinical pharmacology and therapeutics Vol. 79; no. 2; p. P7
Main Authors:	Huang, S. M., Reynolds, K. S., Strong, J. M., Nallani, S. C., Lesko, L. J., Temple, R., Abraham, S., Alhabet, S., Baweja, R., Chung, S. M., Colangelo, P., Collins, J. M., Frucht, D., Green, M. D., Hepp, P., Kavanagh, R., Ko, H. S., Marroum, P., Qiu, W., Rahman, A., Sobel, S., Stifano, T., Wei, X., Yasuda, S. U., Zhang, L.
Format:	Journal Article
Language:	English
Published:	01-02-2006
Online Access:	Get full text
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Summary:	AIMS Creation of a concept paper that reflects the Agency's current view that the metabolism of a new drug should be adequately characterized and its potential to interact with other drugs should be explored as part of the assessment of safety and effectiveness. METHODS Latest scientific consensus on drug metabolism, transport, and pharmacokinetics was considered, based on discussions at conferences, advisory committee meetings, and consultation with experts. RESULTS Evaluation of drug interactions involves an integration of in vitro and in vivo assessments, as indicated by a decision tree. The concept paper features: 1) principles and details of in vitro and in vivo study conduct, including up‐to‐date information on in vitro metabolic profiling, inhibition, and induction studies, 2) lists of probe CYP substrates, inhibitors and inducers, 3) how specific results from in vitro studies may be interpreted to determine the need for in vivo investigations, 4) in vitro and in vivo study designs to evaluate the potential for interactions related to drug transporters, particularly P‐gp, 5) discussion of labeling recommendations. CONCLUSIONS The concept paper (http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004‐4079b1.htm) includes current Agency recommendations for in vitro and in vivo drug metabolism and drug interaction studies performed during drug development. The concept paper includes a decision tree that emphasizes an integrated approach to the evaluation of drug interactions. Clinical Pharmacology & Therapeutics (2005) 79, P7–P7; doi: 10.1016/j.clpt.2005.12.023
ISSN:	0009-9236 1532-6535
DOI:	10.1016/j.clpt.2005.12.023