Adme-Enabling Technologies in Drug Design and Development

Herausgegeben von Zhang, Donglu; Surapaneni, Sekhar

• Gebundenes Buch

Produktbeschreibung

A comprehensive guide to cutting-edge tools in ADME research

The 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 text

Scientists 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.

Produktdetails

• Verlag: Wiley & Sons
• Artikelnr. des Verlages: 14554278000
• 1. Auflage
• Seitenzahl: 622
• Erscheinungstermin: 30. April 2012
• Englisch
• Abmessung: 286mm x 221mm x 38mm
• Gewicht: 1655g
• ISBN-13: 9780470542781
• ISBN-10: 0470542780
• Artikelnr.: 35046654

Autorenporträt

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.

Inhaltsangabe

FOREWORD xxi Lisa A. Shipley PREFACE xxv Donglu Zhang and Sekhar Surapaneni
CONTRIBUTORS xxvii PART A ADME: OVERVIEW AND CURRENT TOPICS 1 1 Regulatory
Drug Disposition and NDA Package Including MIST 3 Sekhar Surapaneni
References 12 2 Optimal ADME Properties for Clinical Candidate and
Investigational New Drug (IND) Package 15 Rajinder Bhardwaj and Gamini
Chandrasena References 25 3 Drug Transporters in Drug Interactions and
Disposition 29 Imad Hanna and Ryan M. Pelis References 46 4 Pharmacological
and Toxicological Activity of Drug Metabolites 55 W. Griffith Humphreys
References 63 5 Improving the Pharmaceutical Properties of Biologics in
Drug Discovery: Unique Challenges and Enabling Solutions 67 Jiwen Chen and
Ashok Dongre References 75 6 Clinical Dose Estimation Using
Pharmacokinetic/Pharmacodynamic Modeling and Simulation 79 Lingling Guan
References 93 7 Pharmacogenomics and Individualized Medicine 95 Anthony
Y.H. Lu and Qiang Ma Disclaimer 105 Contact Information 105 References 105
8 Overview of Drug Metabolism and Pharmacokinetics with Applications in
Drug Discovery and Development in China 109 Chang-Xiao Liu References 125
PART B ADME SYSTEMS AND METHODS 129 9 Technical Challenges and Recent
Advances of Implementing Comprehensive ADMET Tools in Drug Discovery 131
Jianling Wang and Leslie Bell Acknowledgments 155 References 155 10
Permeability and Transporter Models in Drug Discovery and Development 161
Praveen V. Balimane, Yong-Hae Han, and Saeho Chong References 167 11
Methods for Assessing Blood-Brain Barrier Penetration in Drug Discovery 169
Li Di and Edward H. Kerns References 174 12 Techniques for Determining
Protein Binding in Drug Discovery and Development 177 Tom Lloyd
Acknowledgment 185 References 185 13 Reaction Phenotyping 189 Chun Li and
Nataraj Kalyanaraman References 206 14 Fast and Reliable CYP Inhibition
Assays 213 Ming Yao, Hong Cai, and Mingshe Zhu References 230 15 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-Genthe References 246 16 Animal Models for Studying Drug
Metabolizing Enzymes and Transporters 253 Kevin L. Salyers and Yang Xu
Acknowledgments 271 References 271 17 Milk Excretion and Placental Transfer
Studies 277 Matthew Hoffmann and Adam Shilling References 289 18 Human Bile
Collection for ADME Studies 291 Suresh K. Balani, Lisa J. Christopher, and
Donglu Zhang Acknowledgment 297 References 297 PART C ANALYTICAL
TECHNOLOGIES 299 19 Current Technology and Limitation of LC-MS 301 Cornelis
E.C.A. Hop References 314 20 Application of Accurate Mass Spectrometry for
Metabolite Identification 317 Zhoupeng Zhang and Kaushik Mitra References
329 21 Applications of Accelerator Mass Spectrometry (AMS) 331 Xiaomin
Wang, Voon Ong, and Mark Seymour References 337 22 Radioactivity Profiling
339 Wing Wah Lam, Jose Silva, and Heng-Keang Lim Acknowledgments 349
References 349 23 A Robust Methodology for Rapid Structure Determination of
Microgram-Level Drug Metabolites by NMR Spectroscopy 353 Kim A. Johnson,
Stella Huang, and Yue-Zhong Shu References 362 24 Supercritical Fluid
Chromatography 363 Jun Dai, Yingru Zhang, David B. Wang-Iverson, and
Adrienne A. Tymiak References 376 25 Chromatographic Separation Methods 381
Wenying Jian, Richard W. Edom, Zhongping (John) Lin, and Naidong Weng
References 396 26 Mass Spectrometric Imaging for Drug Distribution in
Tissues 401 Daniel P. Magparangalan, Timothy J. Garrett, Dieter M. Drexler,
and Richard A. Yost References 414 27 Applications of Quantitative
Whole-Body Autoradiography (QWBA) in Drug Discovery and Development 419
Lifei Wang, Haizheng Hong, and Donglu Zhang References 433 PART D NEW AND
RELATED TECHNOLOGIES 435 28 Genetically Modified Mouse Models in ADME
Studies 437 Xi-Ling Jiang and Ai-Ming Yu References 448 29 Pluripotent Stem
Cell Models in Human Drug Development 455 David C. Hay References 458 30
Radiosynthesis for ADME Studies 461 Brad D. Maxwell and Charles S. Elmore
References 471 31 Formulation Development for Preclinical in vivo Studies
473 Yuan-Hon Kiang, Darren L. Reid, and Janan Jona References 482 32 In
vitro Testing of Proarrhythmic Toxicity 485 Haoyu Zeng and Jiesheng Kang
References 492 33 Target Engagement for PK/PD Modeling and Translational
Imaging Biomarkers 493 Vanessa N. Barth, Elizabeth M. Joshi, and Matthew D.
Silva References 508 34 Applications of iRNA Technologies in Drug
Transporters and Drug Metabolizing Enzymes 513 Mingxiang Liao and Cindy Q.
Xia Acknowledgment 539 References 539 Appendix Drug Metabolizing Enzymes
and Biotransformation Reactions 545 Natalia Penner, Caroline Woodward, and
Chandra Prakash Acknowledgment 562 References 562 Index 567

Rezensionen

"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)