ADME-Enabling Technologies in Drug Design and Development

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Donglu Zhang, Sekhar Surapaneni
John Wiley & Sons, Apr 30, 2012 - Medical - 622 pages
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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.

 

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Contents

Regulatory Drug Disposition and NDA Package Including MIST
3
Optimal ADME Properties for Clinical Candidate
15
Drug Transporters in Drug Interactions and Disposition
29
Pharmacological and Toxicological Activity of Drug Metabolites
55
Improving the Pharmaceutical Properties of Biologics
67
Clinical Dose Estimation Using PharmacokineticPharmacodynamic
79
Pharmacogenomics and Individualized Medicine
95
Overview of Drug Metabolism and Pharmacokinetics with
109
Applications of Accelerator Mass Spectrometry AMS
331
Radioactivity Profiling
339
A Robust Methodology for Rapid Structure Determination
353
Supercritical Fluid Chromatography
363
Chromatographic Separation Methods
381
References
396
References
414
Applications of Quantitative WholeBody Autoradiography
419

Technical Challenges and Recent Advances of Implementing
131
Due to the FirstPass Effect
139
Permeability and Transporter Models in Drug Discovery
161
Methods for Assessing BloodBrain Barrier Penetration
169
Techniques for Determining Protein Binding in Drug Discovery
177
Reaction Phenotyping
189
Fast and Reliable CYP Inhibition Assays
213
Tools and Strategies for the Assessment of Enzyme Induction
233
Animal Models for Studying Drug Metabolizing Enzymes
253
Milk Excretion and Placental Transfer Studies
277
Human Bile Collection for ADME Studies
291
Current Technology and Limitation of LCMS
301
Application of Accurate Mass Spectrometry
317
Dosimetry Calculation
425
References
433
Pluripotent Stem Cell Models in Human Drug Development
455
Radiosynthesis for ADME Studies
461
Formulation Development for Preclinical in vivo Studies
473
In vitro Testing of Proarrhythmic Toxicity
485
References
492
References
508
and Transporters
527
Appendix Drug Metabolizing Enzymes and Biotransformation Reactions
545
Conjugative Phase II DMEs
553
Acknowledgment
562
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About the author (2012)

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.

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