{"product_id":"drug-drug-interactions-in-pharmaceutical-development-hardback-9780471794417","title":"Drug-Drug Interactions in Pharmaceutical Development (Hardback) 9780471794417","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eDrug-Drug Interactions in Pharmaceutical Development\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cfont size=\"4\"\u003eAlbert P. Li (Edited by), AP Li (Author), Binghe Wang (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780471794417, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 11 December 2007\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e272 pages\u003cbr\u003e24.1 x 16.3 x 2.2 cm, 0.583 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\"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\" (\u003ci\u003eGood Clinical Practice Journal\u003c\/i\u003e, June 2008)\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003ci\u003eDrug-Drug Interactions in Pharmaceutical Development\u003c\/i\u003e comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePreface.  \u003cp\u003eContributors.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 In Vitro Evaluation of Metabolic Drug–Drug Interactions: Concepts and Practice\u003c\/b\u003e (\u003ci\u003eAlbert P. Li\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e1.1 Introduction.\u003c\/p\u003e \u003cp\u003e1.2 Mechanisms of Adverse Drug–Drug Interactions.\u003c\/p\u003e \u003cp\u003e1.2.1 Pharmacological Interactions.\u003c\/p\u003e \u003cp\u003e1.2.2 Pharmacokinetic Interactions.\u003c\/p\u003e \u003cp\u003e1.3 Drug Metabolism.\u003c\/p\u003e \u003cp\u003e1.3.1 Phase I Oxidation.\u003c\/p\u003e \u003cp\u003e1.3.2 Phase II Conjugation.\u003c\/p\u003e \u003cp\u003e1.4 CYP Isoforms.\u003c\/p\u003e \u003cp\u003e1.5 Human In Vitro Experimental Systems for Drug Metabolism.\u003c\/p\u003e \u003cp\u003e1.5.1 Hepatocytes.\u003c\/p\u003e \u003cp\u003e1.5.2 Liver Postmitochondrial Supernatant (PMS).\u003c\/p\u003e \u003cp\u003e1.5.3 Human Liver Microsomes.\u003c\/p\u003e \u003cp\u003e1.5.4 Recombinant P450 Isoforms (rCYP).\u003c\/p\u003e \u003cp\u003e1.5.5 Cytosol.\u003c\/p\u003e \u003cp\u003e1.6 Mechanisms of Metabolic Drug–Drug Interactions.\u003c\/p\u003e \u003cp\u003e1.7 Mechanism-Based Approach for Evaluation of Drug–Drug Interaction Potential.\u003c\/p\u003e \u003cp\u003e1.7.1 Metabolic Phenotyping.\u003c\/p\u003e \u003cp\u003e1.7.2 Evaluation of Inhibitory Potential for Drug-Metabolizing Enzymes.\u003c\/p\u003e \u003cp\u003e1.7.3 Induction Potential for Drug-Metabolizing Enzymes.\u003c\/p\u003e \u003cp\u003e1.8 Experimental Approaches for In Vitro Evaluation of Drug–Drug Interaction Potential.\u003c\/p\u003e \u003cp\u003e1.8.1 Study 1: Metabolic Phenotyping 1—Metabolite Identification.\u003c\/p\u003e \u003cp\u003e1.8.2 Study 2: Metabolic Phenotyping 2—Identification of Major Metabolic Pathways.\u003c\/p\u003e \u003cp\u003e1.8.3 Study 3: Metabolic Phenotyping 3—Identification of P450 Isoform Pathways (P450 Phenotyping).\u003c\/p\u003e \u003cp\u003e1.8.4 Study 4: CYP Inhibitory Potential.\u003c\/p\u003e \u003cp\u003e1.8.5 Study 5: Enzyme Induction Potential.\u003c\/p\u003e \u003cp\u003e1.8.6 Study 6: In Vitro Empirical Drug–Drug Interactions.\u003c\/p\u003e \u003cp\u003e1.9 Data Interpretation.\u003c\/p\u003e \u003cp\u003e1.9.1 Pathway Evaluation.\u003c\/p\u003e \u003cp\u003e1.9.2 P450 Inhibition.\u003c\/p\u003e \u003cp\u003e1.9.3 P450 Induction.\u003c\/p\u003e \u003cp\u003e1.10 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 In Vitro Approaches to Anticipating Clinical Drug Interactions\u003c\/b\u003e (\u003ci\u003eLaurie P. Volak, David J. Greenblatt, and Lisa L. von Moltke\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e2.1 In Vitro Systems for Human CYP450 Metabolism.\u003c\/p\u003e \u003cp\u003e2.1.1 Incubation Buffer (pH and Ionic Strength).\u003c\/p\u003e \u003cp\u003e2.1.2 MgCl\u003csub\u003e2\u003c\/sub\u003e and Cytochrome b5.\u003c\/p\u003e \u003cp\u003e2.1.3 Nonspecific Binding.\u003c\/p\u003e \u003cp\u003e2.1.4 Organic Solvents and Excipients.\u003c\/p\u003e \u003cp\u003e2.2 Analysis of Data from In Vitro Systems.\u003c\/p\u003e \u003cp\u003e2.2.1 Linear Transformation of Michaelis–Menten Equation (Lineweaver–Burk and Eadie–Hofstee).\u003c\/p\u003e \u003cp\u003e2.2.2 Nonlinear Regression Analysis of Hyperbolic Kinetic Data.\u003c\/p\u003e \u003cp\u003e2.2.3 Consideration of Non-Michaelis–Menten Kinetics.\u003c\/p\u003e \u003cp\u003e2.3 Use of In Vitro Kinetic Data to Predict In Vivo Clearance.\u003c\/p\u003e \u003cp\u003e2.3.1 Calculation of In Vitro (Predicted) Hepatic Clearance.\u003c\/p\u003e \u003cp\u003e2.3.2 Comparison of In Vitro (Predicted) with In Vivo Hepatic Clearance.\u003c\/p\u003e \u003cp\u003e2.4 Use of In Vitro Kinetic Data to Predict Drug–Drug Interactions.\u003c\/p\u003e \u003cp\u003e2.4.1 Choice of Probe Substrates for Inhibition Studies.\u003c\/p\u003e \u003cp\u003e2.4.2 Determining the Mechanism of CYP450 Inhibition.\u003c\/p\u003e \u003cp\u003e2.4.3 Prediction of In Vivo Drug–Drug Inhibition Interactions from In Vitro Data.\u003c\/p\u003e \u003cp\u003e2.5 Consideration of Non-CYP Enzymatic Systems.\u003c\/p\u003e \u003cp\u003e2.5.1 Flavin-Containing Monooxygenase (FMO).\u003c\/p\u003e \u003cp\u003e2.5.2 UDP-glucuronosyltransferase (UGT).\u003c\/p\u003e \u003cp\u003e2.5.3 Sulfotransferase (SULT).\u003c\/p\u003e \u003cp\u003e2.5.4 N-Acetyltransferase (NAT).\u003c\/p\u003e \u003cp\u003e2.5.5 Methyltransferase.\u003c\/p\u003e \u003cp\u003e2.5.6 Epoxidase Hydrolase.\u003c\/p\u003e \u003cp\u003e2.5.7 Aldehyde Oxidase and Dehydrogenase.\u003c\/p\u003e \u003cp\u003e2.5.8 Glutathione-S-transferase (GST).\u003c\/p\u003e \u003cp\u003e2.6 Summary.\u003c\/p\u003e \u003cp\u003e2.7 Acknowledgments.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Inhibition of Drug-Metabolizing Enzymes and Drug–Drug Interactions in Drug Discovery and Development\u003c\/b\u003e (\u003ci\u003eR. Scott Obach\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e3.1 Introduction.\u003c\/p\u003e \u003cp\u003e3.2 Laboratory Approaches Inhibiting Drug-Metabolizing Enzymes.\u003c\/p\u003e \u003cp\u003e3.2.1 Analytical Method.\u003c\/p\u003e \u003cp\u003e3.2.2 Determination of Linearity of Velocity.\u003c\/p\u003e \u003cp\u003e3.2.3 Substrate Saturation Experiment.\u003c\/p\u003e \u003cp\u003e3.2.4 Reversible Inhibition Experiments: K\u003csub\u003ei\u003c\/sub\u003e.\u003c\/p\u003e \u003cp\u003e3.2.5 Reversible Inhibition Experiments: IC\u003csub\u003e50\u003c\/sub\u003e.\u003c\/p\u003e \u003cp\u003e3.3 Selection of Substrates for Inhibition Experiments in Drug Metabolism.\u003c\/p\u003e \u003cp\u003e3.4 Inhibition of Drug-Metabolizing Enzymes in Drug Discovery and Development.\u003c\/p\u003e \u003cp\u003e3.4.1 Inhibition Experiments in Early Drug Discovery.\u003c\/p\u003e \u003cp\u003e3.4.2 Inhibition Experiments in Late Drug Discovery.\u003c\/p\u003e \u003cp\u003e3.4.3 Inhibition Experiments During Drug Development.\u003c\/p\u003e \u003cp\u003e3.5 Summary.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Mechanism-Based CYP Inhibition: Enzyme Kinetics, Assays, and Prediction of Human Drug–Drug Interactions\u003c\/b\u003e (\u003ci\u003eMagang Shou\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e4.1 Kinetic Model for Mechanism-Based Inhibition.\u003c\/p\u003e \u003cp\u003e4.2 Methodological Measurements of Kinetic Parameters.\u003c\/p\u003e \u003cp\u003e4.3 Incubation.\u003c\/p\u003e \u003cp\u003e4.3.1 CYP Isoform-Specific Assays.\u003c\/p\u003e \u003cp\u003e4.3.2 General Incubation Procedure and Sample Preparation.\u003c\/p\u003e \u003cp\u003e4.3.3 LC-MS–MS Analysis.\u003c\/p\u003e \u003cp\u003e4.3.4 Data Analysis.\u003c\/p\u003e \u003cp\u003e4.4 Prediction of Human DDIs from In Vitro MBI Data.\u003c\/p\u003e \u003cp\u003e4.5 Acknowledgments.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Genomic Approaches To Drug–Drug Interactions\u003c\/b\u003e (\u003ci\u003eYi Yang and Jeffrey F. Waring\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e5.1 Introduction.\u003c\/p\u003e \u003cp\u003e5.2 DNA Microarrays.\u003c\/p\u003e \u003cp\u003e5.2.1 Array Platforms.\u003c\/p\u003e \u003cp\u003e5.2.2 Gene Expression Profiling Using Microarray.\u003c\/p\u003e \u003cp\u003e5.2.3 Genotyping Using Microarray.\u003c\/p\u003e \u003cp\u003e5.3 Genomic Application Toward the Prediction of DDIs.\u003c\/p\u003e \u003cp\u003e5.3.1 Gene Expression Profiling of Compound Mixtures.\u003c\/p\u003e \u003cp\u003e5.3.2 Expression Profiling of DMEs and Transporters.\u003c\/p\u003e \u003cp\u003e5.3.3 Identification of Gene Expression Patterns Indicative of DDIs.\u003c\/p\u003e \u003cp\u003e5.4 Genomics Approach to Decipher the Molecular Basis of DDI: Nuclear Receptors.\u003c\/p\u003e \u003cp\u003e5.5 Genomic Approaches to Address the Genetic Variability in DDIs.\u003c\/p\u003e \u003cp\u003e5.6 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Transporters and Drug Interactions\u003c\/b\u003e (\u003ci\u003eYoshihisa Shitara, Toshiharu Horie, and Yuichi Sugiyama\u003c\/i\u003e)\u003c\/p\u003e \u003cp\u003e6.1 Introduction.\u003c\/p\u003e \u003cp\u003e6.2 Interactions Involving Liver Transporters.\u003c\/p\u003e \u003cp\u003e6.2.1 Role of Transporters in the Biliary Excretion of Drugs.\u003c\/p\u003e \u003cp\u003e6.2.2 Transporter-Mediated DDIs in the Process of Hepatobilary Excretion.\u003c\/p\u003e \u003cp\u003e6.2.3 Transporters as a Determinant of Metabolic Rate.\u003c\/p\u003e \u003cp\u003e6.3 Interactions in Intestine Transporters.\u003c\/p\u003e \u003cp\u003e6.3.1 Role of Transporters in Intestinal Absorption.\u003c\/p\u003e \u003cp\u003e6.3.2 Examples of Transporter-Mediated DDIs in the Process of Intestinal Absorption.\u003c\/p\u003e \u003cp\u003e6.4 Drug Toxicity Involving Drug Transporters.\u003c\/p\u003e \u003cp\u003e6.5 Drugs that Affect the Expression or Localization of Transporters.\u003c\/p\u003e \u003cp\u003e6.6 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Transporter-Mediated Drug Interactions: Molecular Mechanisms and Clinical Implications\u003c\/b\u003e (\u003ci\u003eJiunn H. Lin\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e7.1 Introduction.\u003c\/p\u003e \u003cp\u003e7.2 Tissue Distribution and Cellular Location of Transporters.\u003c\/p\u003e \u003cp\u003e7.2.1 Small Intestine.\u003c\/p\u003e \u003cp\u003e7.2.2 Liver.\u003c\/p\u003e \u003cp\u003e7.2.3 Kidney.\u003c\/p\u003e \u003cp\u003e7.2.4 Brain.\u003c\/p\u003e \u003cp\u003e7.3 Molecular Mechanisms for Transporter Inhibition and Induction.\u003c\/p\u003e \u003cp\u003e7.3.1 Inhibition of Transporters.\u003c\/p\u003e \u003cp\u003e7.3.2 Induction of Transporters.\u003c\/p\u003e \u003cp\u003e7.4 Drug Interactions Caused by Transporter Inhibition and Induction.\u003c\/p\u003e \u003cp\u003e7.4.1 Direct Evidence.\u003c\/p\u003e \u003cp\u003e7.4.2 Circumstantial Evidence.\u003c\/p\u003e \u003cp\u003e7.5 Clinical Significance of Transporter-Mediated Drug Interactions.\u003c\/p\u003e \u003cp\u003e7.6 Conclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Recent Case Studies of Clinically Significant Drug–Drug Interactions and the Limits of\u003c\/b\u003e \u003cb\u003eIn Vitro\u003c\/b\u003e \u003cb\u003ePrediction Methodology\u003c\/b\u003e (\u003ci\u003eRené H. Levy, Isabelle Ragueneau-Majlessi, and Carol Collins\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e8.1 Introduction.\u003c\/p\u003e \u003cp\u003e8.2 Case Studies.\u003c\/p\u003e \u003cp\u003e8.2.1 Interaction Between Repaglinide and Gemfibrozil \u003ci\u003eþ\u003c\/i\u003e Itraconazole.\u003c\/p\u003e \u003cp\u003e8.2.2 Interaction Between Ramelteon and Fluvoxamine.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 U.S. Regulatory Perspective: Drug–Drug Interactions\u003c\/b\u003e (\u003ci\u003eJohn Strong and Shiew-Mei Huang\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e9.1 Introduction.\u003c\/p\u003e \u003cp\u003e9.2 An Integrated Approach.\u003c\/p\u003e \u003cp\u003e9.3 Methods for Evaluating Metabolic Clearance In Vitro.\u003c\/p\u003e \u003cp\u003e9.3.1 CYP Reaction Phenotyping.\u003c\/p\u003e \u003cp\u003e9.3.2 CYP Inhibition.\u003c\/p\u003e \u003cp\u003e9.3.3 CYP Induction.\u003c\/p\u003e \u003cp\u003e9.3.4 Other Metabolic Enzymes.\u003c\/p\u003e \u003cp\u003e9.3.5 Transporters.\u003c\/p\u003e \u003cp\u003e9.3.6 GLP Versus Non-GLP Studies.\u003c\/p\u003e \u003cp\u003e9.4 In Vivo Approaches.\u003c\/p\u003e \u003cp\u003e9.4.1 Study Design.\u003c\/p\u003e \u003cp\u003e9.4.2 Data Analysis and Sample Size Consideration.\u003c\/p\u003e \u003cp\u003e9.4.3 Classification of Inhibitors and Labeling Considerations.\u003c\/p\u003e \u003cp\u003e9.4.4 Cocktail Approaches.\u003c\/p\u003e \u003cp\u003e9.4.5 P-gp and Other Transporters.\u003c\/p\u003e \u003cp\u003e9.5 Clinical Cases.\u003c\/p\u003e \u003cp\u003e9.6 Regulatory Considerations.\u003c\/p\u003e \u003cp\u003e9.7 Labeling.\u003c\/p\u003e \u003cp\u003e9.8 Summary.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Herbal Drug Interactions—A Canadian Perspective\u003c\/b\u003e (\u003ci\u003eBrian C. Foster\u003c\/i\u003e)\u003c\/p\u003e \u003cp\u003e10.1 Introduction.\u003c\/p\u003e \u003cp\u003e10.2 Interaction Risk Determination.\u003c\/p\u003e \u003cp\u003e10.3 NHP Products.\u003c\/p\u003e \u003cp\u003e10.3.1 NHP Characterization.\u003c\/p\u003e \u003cp\u003e10.4 Disposition.\u003c\/p\u003e \u003cp\u003e10.5 PD and PK interactions.\u003c\/p\u003e \u003cp\u003e10.5.1 Choice of Substance Concentration Range.\u003c\/p\u003e \u003cp\u003e10.5.2 Role of Animal Studies.\u003c\/p\u003e \u003cp\u003e10.5.3 Human Clinical Studies.\u003c\/p\u003e \u003cp\u003e10.6 Action.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003eIndex.\u003c\/p\u003e \u003cp\u003eWiley Series in Drug Discovery and Development.\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley-Interscience","offers":[{"title":"Brand New","offer_id":52298057875736,"sku":"9780471794417","price":72.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780471794417.jpg?v=1781733464","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/drug-drug-interactions-in-pharmaceutical-development-hardback-9780471794417","provider":"Freshly Printed Books","version":"1.0","type":"link"}