Drug Drug Interactions : Scientific and Regulatory Perspectives

Contents: Foreword. Preface. 1. Overview: pharmacokinetic drug drug interactions/Albert P. Li and Malle Jurima Romet. 2. Role of cytochrome P450 enzymes in Drug drug interactions/F. Peter Guengerish. 3. The liver as a target for chemical chemical interactions/John Michael Sauer, Eric R. Stine, Lhanoo Gunawardhana, Dwayne A. Hill and I. Glenn Sipes. 4. Application of human liver microsomes in metabolism based drug drug interactions: in vitro in vivo correlations and the Abbott Laboratories experience/A. David Rodrigues and Shekman L. Wong. 5. Primary hepatocyte cultures as an in Vitro experimental model for the evaluation of pharmacokinetic drug drug interactions/Albert P. Li. 6. Liver slices as a model in drug metabolism/James L. Ferrero and Klaus Brendel. 7. Use of cDNA expressed human cytochrome P450 enzymes to study potential drug drug interactions/Charles L. Crespi and Bruce W. Penman. 8. Pharmacokinetics of drug interactions/Gregory L. Kedderis. 9. Experimental models for evaluating enzyme induction potential of new drug candidates in animals and humans and a strategy for their use/Thomas N. Thompson. 10. Metabolic drug drug interactions: perspective from FDA medical and clinical pharmacology reviewers/John Dikran Balian and Atiqur Rahman. 11. Drug interactions: perspectives of the Canadian drugs directorate/Malle Jurima Romet. 12. Overview of experimental approaches for study of drug metabolism and drug drug interactions/Frank J. Gonzalez. Index.

This volume presents a comprehensive review of drug-drug interactions from the perspectives of academia, industry, and government regulatory agencies. The topics covered include drug metabolism enzymes, toxicology, in vitro mechanistic approaches, and the regulatory perspectives of drug-drug interactions. Drug-Drug Interactions: Scientific and Regulatory perspectives is intended for  professionals in the pharmaceutical industry, in health care, and in governmental regulatory agencies, who are interested in understanding the mechanisms of drug-drug interactions, predicting the interaction potential of new drugs and avoiding clinically significant drug-drug interactions in patients. It should also be of interest to students and researchers in the areas of pharmacology, toxicology, pharmacokinetics, and medicine.