Binghe Wang

Drug-Drug Interactions in Pharmaceutical Development

Herausgegeben:Li, Albert P.

• Gebundenes Buch

Produktbeschreibung

Early evaluation of potential drug-drug interactions

Addressing the potential for adverse interactions among coadministered drugs before marketing a new drug can save time, money, and lives. In this reference, distinguished international experts comprehensively review the issues, relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. Focusing on evaluation during the drug discovery process, Drug-Drug Interactions in Pharmaceutical Development:
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Details the major scientific concepts and preclinical experimental approaches
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Covers both clinical and nonclinical aspects
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Discusses in vitro and in vivo methodologies
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Covers genomic approaches
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Addresses U.S., European, and Japanese regulations
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Includes a chapter on herbal drug interactions

Compiling current information into one accessible resource, this is an excellent reference for industrial scientists and regulatory specialists in drug development as well as academic researchers and students in the fields of pharmacology, drug metabolism, and toxicology.

Produktdetails

• Wiley Series in Drug Discovery and Development
• Verlag: Wiley & Sons
• Artikelnr. des Verlages: 14679441000
• 1. Auflage
• Seitenzahl: 264
• Erscheinungstermin: 1. November 2007
• Englisch
• Abmessung: 240mm x 161mm x 19mm
• Gewicht: 575g
• ISBN-13: 9780471794417
• ISBN-10: 0471794414
• Artikelnr.: 22846412

Autorenporträt

Albert P. Li is the President and CEO of In Vitro ADMET Laboratories, LLC (www.invitroadmet.com), and Advanced Pharmaceutical Sciences, Inc. (www.apsciences.com), and the cofounder, Chairman, and CSO of the ADMET Group (www.admetgroup.com). Dr. Li has over twenty-five years in the drug development industry, is a distinguished international speaker in the field, and has over 150 publications. He has edited several books.

Inhaltsangabe

Preface. Contributors. 1 In Vitro Evaluation of Metabolic Drug-Drug
Interactions: Concepts and Practice (Albert P. Li). 1.1 Introduction. 1.2
Mechanisms of Adverse Drug-Drug Interactions. 1.3 Drug Metabolism. 1.4 CYP
Isoforms. 1.5 Human In Vitro Experimental Systems for Drug Metabolism. 1.6
Mechanisms of Metabolic Drug-Drug Interactions. 1.7 Mechanism-Based
Approach for Evaluation of Drug-Drug Interaction Potential. 1.8
Experimental Approaches for In Vitro Evaluation of Drug-Drug Interaction
Potential. 1.9 Data Interpretation. 1.10 Conclusion. References. 2 In Vitro
Approaches to Anticipating Clinical Drug Interactions (Laurie P. Volak,
David J. Greenblatt, and Lisa L. von Moltke). 2.1 In Vitro Systems for
Human CYP450 Metabolism. 2.2 Analysis of Data from In Vitro Systems. 2.3
Use of In Vitro Kinetic Data to Predict In Vivo Clearance. 2.4 Use of In
Vitro Kinetic Data to Predict Drug-Drug Interactions. 2.5 Consideration of
Non-CYP Enzymatic Systems. 2.6 Summary. 2.7 Acknowledgments. References. 3
Inhibition of Drug-Metabolizing Enzymes and Drug-Drug Interactions in Drug
Discovery and Development (R. Scott Obach). 3.1 Introduction. 3.2
Laboratory Approaches Inhibiting Drug-Metabolizing Enzymes. 3.3 Selection
of Substrates for Inhibition Experiments in Drug Metabolism. 3.4 Inhibition
of Drug-Metabolizing Enzymes in Drug Discovery and Development. 3.5
Summary. References. 4 Mechanism-Based CYP Inhibition: Enzyme Kinetics,
Assays, and Prediction of Human Drug-Drug Interactions (Magang Shou). 4.1
Kinetic Model for Mechanism-Based Inhibition. 4.2 Methodological
Measurements of Kinetic Parameters. 4.3 Incubation. 4.4 Prediction of Human
DDIs from In Vitro MBI Data. 4.5 Acknowledgments. References. 5 Genomic
Approaches To Drug-Drug Interactions (Yi Yang and Jeffrey F. Waring). 5.1
Introduction. 5.2 DNA Microarrays. 5.3 Genomic Application Toward the
Prediction of DDIs. 5.4 Genomics Approach to Decipher the Molecular Basis
of DDI: Nuclear Receptors. 5.5 Genomic Approaches to Address the Genetic
Variability in DDIs. 5.6 Conclusion. References. 6 Transporters and Drug
Interactions (Yoshihisa Shitara, Toshiharu Horie, and Yuichi Sugiyama) 6.1
Introduction. 6.2 Interactions Involving Liver Transporters. 6.3
Interactions in Intestine Transporters. 6.4 Drug Toxicity Involving Drug
Transporters. 6.5 Drugs that Affect the Expression or Localization of
Transporters. 6.6 Conclusion. References. 7 Transporter-Mediated Drug
Interactions: Molecular Mechanisms and Clinical Implications (Jiunn H.
Lin). 7.1 Introduction. 7.2 Tissue Distribution and Cellular Location of
Transporters. 7.3 Molecular Mechanisms for Transporter Inhibition and
Induction. 7.4 Drug Interactions Caused by Transporter Inhibition and
Induction. 7.5 Clinical Significance of Transporter-Mediated Drug
Interactions. 7.6 Conclusion. References. 8 Recent Case Studies of
Clinically Significant Drug-Drug Interactions and the Limits of In Vitro
Prediction Methodology (René H. Levy, Isabelle Ragueneau-Majlessi, and
Carol Collins). 8.1 Introduction. 8.2 Case Studies. References. 9 U.S.
Regulatory Perspective: Drug-Drug Interactions (John Strong and Shiew-Mei
Huang). 9.1 Introduction. 9.2 An Integrated Approach. 9.3 Methods for
Evaluating Metabolic Clearance In Vitro. 9.4 In Vivo Approaches. 9.5
Clinical Cases. 9.6 Regulatory Considerations. 9.7 Labeling. 9.8 Summary.
References. 10 Herbal Drug Interactions--A Canadian Perspective (Brian C.
Foster) 10.1 Introduction. 10.2 Interaction Risk Determination. 10.3 NHP
Products. 10.4 Disposition. 10.5 PD and PK interactions. 10.6 Action.
References. Index. Wiley Series in Drug Discovery and Development.

Rezensionen

"I am pleased to have read this book from cover-to-cover. I will value owning it and keep it near the front of my bookshelf" ( Good Clinical Practice Journal , June 2008)