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.
Contents
Part A : ADME:
Overview and Current Topics
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1 - Regulatory
Drug Disposition and NDA Package Including MIST
Sekhar
Surapaneni
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2 - Optimal
ADME Properties for Clinical Candidate and Investigational New Drug (IND)
Package
Rajinder
Bhardwaj Gamini Chandrasena
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3 - Drug
Transporters in Drug Interactions and Disposition
Imad
Hanna Ryan M. Pelis
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4 - Pharmacological
and Toxicological Activity of Drug Metabolites
W.
Griffith Humphreys
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5 - Improving
the Pharmaceutical Properties of Biologics in Drug Discovery: Unique Challenges
and Enabling Solutions
Jiwen
Chen Ashok Dongre
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6 - Clinical
Dose Estimation Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation
Lingling
Guan
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7 - Pharmacogenomics
and Individualized Medicine
Anthony
Y. H. Lu Qiang Ma
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8 - Overview
of Drug Metabolism and Pharmacokinetics with Applications in Drug Discovery and
Development in China
Chang‐Xiao
Liu
Part B : ADME
Systems and Methods
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9 - Technical
Challenges and Recent Advances of Implementing Comprehensive ADMET Tools in
Drug Discovery
Jianling
Wang Leslie Bell
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10 - Permeability
and Transporter Models in Drug Discovery and Development
Praveen
V. Balimane Yong‐Hae Han Saeho Chong
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11 - Methods
for Assessing Blood–Brain Barrier Penetration in Drug Discovery
Li
Di Edward H. Kerns
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12 - Techniques
for Determining Protein Binding in Drug Discovery and Development
Tom
Lloyd
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13 - Reaction
Phenotyping
Chun
Li Nataraj Kalyanaraman
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14 - Fast
and Reliable CYP Inhibition Assays
Ming
Yao Hong Cai Mingshe Zhu
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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
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16 - Animal
Models for Studying Drug Metabolizing Enzymes and Transporters
Kevin
L. Salyers Yang Xu
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17 - Milk
Excretion and Placental Transfer Studies
Matthew
Hoffmann Adam Shilling
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18 - Human
Bile Collection for ADME Studies
Suresh
K. Balani Lisa J. Christopher Donglu Zhang
Part C :
Analytical Technologies
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19 - Current
Technology and Limitation of LC‐MS
Cornelis
E. C. A. Hop
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20 - Application
of Accurate Mass Spectrometry for Metabolite Identification
Zhoupeng
Zhang Kaushik Mitra
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21 - Applications
of Accelerator Mass Spectrometry (AMS)
Xiaomin
Wang Voon Ong Mark Seymour
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22 - Radioactivity
Profiling
Wing
Wah Lam Jose Silva Heng‐Keang Lim
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23 - A
Robust Methodology for Rapid Structure Determination of Microgram‐Level Drug
Metabolites by NMR Spectroscopy
Kim
A. Johnson Stella Huang Yue‐Zhong Shu
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24 - Supercritical
Fluid Chromatography
Jun
Dai Yingru Zhang David B. Wang‐Iverson Adrienne A. Tymiak
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25 - Chromatographic
Separation Methods
Wenying
Jian Richard W. Edom Zhongping (john) Lin Naidong Weng
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26 - Mass
Spectrometric Imaging for Drug Distribution in Tissues
Daniel
P. Magparangalan Timothy J. Garrett Dieter M. Drexler Richard A. Yost
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27 - Applications
of Quantitative Whole‐Body Autoradiography (QWBA) in Drug Discovery and
Development
Lifei
Wang Haizheng Hong Donglu Zhang
Part D : New and
Related Technologies
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28 - Genetically
Modified Mouse Models in ADME Studies
Xi‐Ling
Jiang Ai‐Ming Yu
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29 - Pluripotent
Stem Cell Models in Human Drug Development
David
C. Hay
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30 - Radiosynthesis
for ADME Studies
Brad
D. Maxwell Charles S. Elmore
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31 - Formulation
Development for Preclinical in vivo Studies
Yuan‐Hon
Kiang Darren L. Reid Janan Jona
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32 - In
vitro Testing of Proarrhythmic Toxicity
Haoyu
Zeng Jiesheng Kang
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33 - Target
Engagement for PK/PD Modeling and Translational Imaging Biomarkers
Vanessa
N. Barth Elizabeth M. Joshi Matthew D. Silva
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34 - Applications
of iRNA Technologies in Drug Transporters and Drug Metabolizing Enzymes
Mingxiang
Liao Cindy Q. Xia
Apdx -
Drug Metabolizing Enzymes and Biotransformation Reactions
Index
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