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Zhang, Donglu (Herausgeber); Surapaneni, Sekhar (Herausgeber)

Adme-Enabling Technologies in Drug Design and Development (Gebundene Ausgabe)

JOHN WILEY & SONS INC, Wiley, John, & Sons, Inc, April 2012

New - 622 S. - Sprache: Englisch - 279x216x38 mm

ISBN: 0470542780 EAN: 9780470542781

A comprehensive guide to cutting-edge tools in ADME researchThe last decade has seen tremendous progress in the development of analytical techniques such as mass spectrometry and molecular biology tools, resulting in important advances in drug discovery, particularly in the area of absorption, distribution, metabolism, and excretion (ADME).ADME-Enabling Technologies in Drug Design and Development focuses on the current state of the art in the field, presenting a comprehensive review of the latest tools for generating ADME data in drug discovery. It examines the broadest possible range of available technologies, giving readers the information they need to choose the right tool for a given application, a key requisite for obtaining favorable results in a timely fashion for regulatory filings. With over thirty contributed chapters by an international team of experts, the book provides: * A thorough examination of current tools, covering both electronic/mechanical technologies and biologically based ones * Coverage of applications for each technology, including key parameters, optimal conditions for intended results, protocols, and case studies * Detailed discussion of emerging tools and techniques, from stem cells and genetically modified animal models to imaging technologies * Numerous figures and diagrams throughout the textScientists and researchers in drug metabolism, pharmacology, medicinal chemistry, pharmaceutics, toxicology, and bioanalytical science will find ADME-Enabling Technologies in Drug Design and Development an invaluable guide to the entire drug development process, from discovery to regulatory issues.

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FOREWORD xxi Lisa A. ShipleyPREFACE xxv Donglu Zhang and Sekhar SurapaneniCONTRIBUTORS xxviiPART A ADME: OVERVIEW AND CURRENT TOPICS 11 Regulatory Drug Disposition and NDA Package Including MIST 3 Sekhar SurapaneniReferences 122 Optimal ADME Properties for Clinical Candidate and Investigational New Drug (IND) Package 15 Rajinder Bhardwaj and Gamini ChandrasenaReferences 253 Drug Transporters in Drug Interactions and Disposition 29 Imad Hanna and Ryan M. PelisReferences 464 Pharmacological and Toxicological Activity of Drug Metabolites 55 W. Griffith HumphreysReferences 635 Improving the Pharmaceutical Properties of Biologics in Drug Discovery: Unique Challenges and Enabling Solutions 67 Jiwen Chen and Ashok DongreReferences 756 Clinical Dose Estimation Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation 79 Lingling GuanReferences 937 Pharmacogenomics and Individualized Medicine 95 Anthony Y.H. Lu and Qiang MaDisclaimer 105Contact Information 105References 1058 Overview of Drug Metabolism and Pharmacokinetics with Applications in Drug Discovery and Development in China 109 Chang-Xiao LiuReferences 125PART B ADME SYSTEMS AND METHODS 1299 Technical Challenges and Recent Advances of Implementing Comprehensive ADMET Tools in Drug Discovery 131 Jianling Wang and Leslie BellAcknowledgments 155References 15510 Permeability and Transporter Models in Drug Discovery and Development 161 Praveen V. Balimane, Yong-Hae Han, and Saeho ChongReferences 16711 Methods for Assessing Blood-Brain Barrier Penetration in Drug Discovery 169 Li Di and Edward H. KernsReferences 17412 Techniques for Determining Protein Binding in Drug Discovery and Development 177 Tom LloydAcknowledgment 185References 18513 Reaction Phenotyping 189 Chun Li and Nataraj KalyanaramanReferences 20614 Fast and Reliable CYP Inhibition Assays 213 Ming Yao, Hong Cai, and Mingshe ZhuReferences 23015 Tools and Strategies for the Assessment of Enzyme Induction in Drug Discovery and Development 233 Adrian J. Fretland, Anshul Gupta, Peijuan Zhu, and Catherine L. Booth-GentheReferences 24616 Animal Models for Studying Drug Metabolizing Enzymes and Transporters 253 Kevin L. Salyers and Yang XuAcknowledgments 271References 27117 Milk Excretion and Placental Transfer Studies 277 Matthew Hoffmann and Adam ShillingReferences 28918 Human Bile Collection for ADME Studies 291 Suresh K. Balani, Lisa J. Christopher, and Donglu ZhangAcknowledgment 297References 297PART C ANALYTICAL TECHNOLOGIES 29919 Current Technology and Limitation of LC-MS 301 Cornelis E.C.A. HopReferences 31420 Application of Accurate Mass Spectrometry for Metabolite Identification 317 Zhoupeng Zhang and Kaushik MitraReferences 32921 Applications of Accelerator Mass Spectrometry (AMS) 331 Xiaomin Wang, Voon Ong, and Mark SeymourReferences 33722 Radioactivity Profiling 339 Wing Wah Lam, Jose Silva, and Heng-Keang LimAcknowledgments 349References 34923 A Robust Methodology for Rapid Structure Determination of Microgram-Level Drug Metabolites by NMR Spectroscopy 353 Kim A. Johnson, Stella Huang, and Yue-Zhong ShuReferences 36224 Supercritical Fluid Chromatography 363 Jun Dai, Yingru Zhang, David B. Wang-Iverson, and Adrienne A. TymiakReferences 37625 Chromatographic Separation Methods 381 Wenying Jian, Richard W. Edom, Zhongping (John) Lin, and Naidong WengReferences 39626 Mass Spectrometric Imaging for Drug Distribution in Tissues 401 Daniel P. Magparangalan, Timothy J. Garrett, Dieter M. Drexler, and Richard A. YostReferences 41427 Applications of Quantitative Whole-Body Autoradiography (QWBA) in Drug Discovery and Development 419 Lifei Wang, Haizheng Hong, and Donglu ZhangReferences 433PART D NEW AND RELATED TECHNOLOGIES 43528 Genetically Modified Mouse Models in ADME Studies 437 Xi-Ling Jiang and Ai-Ming YuReferences 44829 Pluripotent Stem Cell Models in Human Drug Development 455 David C. HayReferences 45830 Radiosynthesis for ADME Studies 461 Brad D. Maxwell and Charles S. ElmoreReferences 47131 Formulation Development for Preclinical in vivo Studies 473 Yuan-Hon Kiang, Darren L. Reid, and Janan JonaReferences 48232 In vitro Testing of Proarrhythmic Toxicity 485 Haoyu Zeng and Jiesheng KangReferences 49233 Target Engagement for PK/PD Modeling and Translational Imaging Biomarkers 493 Vanessa N. Barth, Elizabeth M. Joshi, and Matthew D. SilvaReferences 50834 Applications of iRNA Technologies in Drug Transporters and Drug Metabolizing Enzymes 513 Mingxiang Liao and Cindy Q. XiaAcknowledgment 539References 539Appendix Drug Metabolizing Enzymes and Biotransformation Reactions 545 Natalia Penner, Caroline Woodward, and Chandra PrakashAcknowledgment 562References 562Index 567

Über den Autor

Donglu Zhang, PhD, is a Principal Scientist in Pharmaceutical Candidate Optimization at Bristol-Myers Squibb in Princeton, New Jersey. He has published seventy peer-reviewed articles, codiscovered the Mass Defect Filtering technique, and coedited two books.Sekhar Surapaneni, PhD, is Director, DMPK, at Celgene Corporation in New Jersey. He has published extensively in peer-reviewed journals and is a member of ISSX and ACS.


"This book fills time needs of ADME researchers and provides a fine reference book for scientists engaged in the areas of medicinal chemistry, pharmaceutics, bioanalytical sciences, pharmacology and toxicology in academia and pharmaceutical industry." ( British Toxicology Society , 1 July 2013)

ISBN 0-470542-78-0, ISBN 0-47-054278-0, ISBN 0-47054-278-0, ISBN 0-470-54278-0, ISBN 0-4705-4278-0

ISBN 978-0-470542-78-1, ISBN 978-0-47-054278-1, ISBN 978-0-47054-278-1, ISBN 978-0-470-54278-1, ISBN 978-0-4705-4278-1

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