Adme-Enabling Technologies in Drug Design and Development, Gebunden

Beschreibung

This book comprehensively covers the state-of-the-art and cutting-edge technologies in an integrated fashion for applications in ADME studies of small molecular drugs. Each chapter provides descriptions of the technologies, application scope and limitations, optimal conditions for intended results, protocols, case studies, and future developments. By concisely describing these technologies, the book provides a useful tool for drug metabolism scientists and as a reference for scientists in the fields of pharmacology, medicinal chemistry, pharmaceutics, toxicology, bioanalytical science in academia and industry.

Inhaltsangabe

Preface
Dongle Zhang and Sekhar Surapaneni
Forward
Lisa A Shipley
Part A. ADME: Overview and Current Topics
1.Regulatory drug disposition and NDA package including MIST
Sekhar Surapaneni
2. Optimal ADME properties of a clinical candidate and investigational new drug (IND) package
Rajinder Bhardwaj and Gamini Chandrasena
3. Drug transporters in Drug interactions and disposition
Imad Hanna and Ryan Pelis
4. Pharmacological and toxicological activity of drug metabolites
W. Griffith Humphreys
5. Improving the pharmaceutical properties of biologics in drug discovery: Unique challenges and enabling solutions
Jiwen Chen and Ashok Dongre
6. Clinical dose estimation using pharmacokinetic / pharmacodynamic simulation and modeling
Lingling Guan
7. Pharmacogenomics and individualized medicines
Anthony Lu and Qiang Ma
8. Overview of pharmacokinetic and drug metabolism with applications to drug discovery and development in China
Changxiao Liu
Part B. ADMET Systems and Methods
9. Technical challenges and recent advances of implementing comprehensive ADMET tools in drug discovery and development
Jianling Wang and Leslie Bell
10. Permeability and Transporter models in drug discovery and development
Praveen Balimane, Yonghae Han, Saeho Chang
11. Methods to assess blood brain penetration in drug discovery
Di Li and Edwards H. Kerns
12. Protein binding determination and application
Tom Lloyd
13. Reaction phenotyping
Chun Li and Nataraj Kalyanaramn
14. Fast and reliable CYP inhibition assays
Ming Yao, Hong Cai, and Mingshe Zhu
15. Tools and strategies for the assessment of enzyme induction in drug discovery and development
Adrian J. Fretland, Anshul Gupta, Peijuan Zhu, Catherine L. Booth-Genthe
16. Animal models for studying metabolizing enzymes and transporters
Kevin L. Salyers and Xu Yang
17. Milk excretion and placenta studies
Matt Hoffman and Adam Schilling
18. Bile collection from animals and humans
Suresh Balani, Lisa Christopher, and Donglu Zhang
Part C Analytical Technologies
19. Current technology and limitation of LC/MS
Cornelis Hop
20. Applications of accurate mass in metabolite identification
Zhoupeng Zhang and Kausick Mitra
21. Applications of accelerated mass spectrometry
Xiaomin Wang, Voon Ong, and Mark Seymour
22. Radioactivity profiling
Wing Wah Lam, Jose Silva, Lining Cai, and Heng-Keang Lim
23. Small scale NMR analysis for metabolite identification
Kim a Johnson, Stella Huang, and Yuezhong Shu
24. Super-critical fluid chromatography for compound isolation
Jun Dai, Yingru Zhang, David B. Wang-Iverson, AdrienneTymiak
25. Chromatographic separation methods
Wenying Jian, Richard W. Edom, Zhongping (John) Lin, and Naidong Weng
26. Mass spectrometric imaging for drug distribution in tissues
Daniel P. Magparangalan, Timothy J. Garrett, Dieter M. Drexler, Richard A. Yost
27. QWBA applications in drug distribution
Lifei Wang, Haizheng Hong, and Donglu Zhang
Part D. New and Related Technologies
28. Genetically modified mouse models in ADME studies
Xiling Jiang and Aiming Yu
29. Pluripotent stem cells have an important role in human drug development
David Hay
30. Radiosynthesis for ADME studies
Brad Maxwell and Chad Elmore
31. Formulation development for preclinical in-vivo studies
Yuan-Hon Kiang, Darren Reid, and Janan Jona
32. In vitro testing of cardiovascular toxicity
Jiesheng Kang and Haoyu Zeng
33. Target engagement for PK-PD modeling and translational biomarkers
Vanessa N. Barth, Elizabeth M. Joshi, Matt Silva
34. Applications of siRNA technologies in drug transporters and drug metabolizing enzymes
Mingxiang Liao and Cindy Xia

Klappentext

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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