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Predictive Approaches in Drug Discovery and Development Biomarkers and In Vitro / In Vivo Corre...

ISBN: 9780470170830 | 0470170832
Edition: 1st
Format: Hardcover
Publisher: Wiley
Pub. Date: 4/10/2012

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SummaryTable of ContentsAuthor Biography
Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discuss... MORE
Prefacep. xi
Acknowledgmentsp. xiii
Contributorsp. xv
Biomarkers in Drug Discoveryp. 1
The Importance of Biomarkers in Translational Medicinep. 3
Validation of Biochemical Biomarker Assays used in Drug Discovery and Development: A Review of Challenges and Solutionsp. 23
Proteomic Methods to Develop Protein Biomarkersp. 49
Overview of Metabolomics Basi... MOREp. 79
Clinical Application of Biomarkersp. 139
Vascular Biomarkers and Imaging Studiesp. 141
Cardiovascular Biomarkers as Examples of Success and Failure in Predicting Safety in Humansp. 163
The Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug Developmentp. 189
Biosensors for Clinical Biomarkersp. 203
Regulatory Perspectivesp. 229
Regulatory Perspectives on Biomarker Developmentp. 231
Perspectives from the European Regulatory Authoritiesp. 255
Use of Biomarker in Drug Development-Japanese Perspectivesp. 269
Predicting in VIVOp. 289
In Vitro-In Vivo Correlations of Hepatic Drug Clearancep. 291
The Potential of In Silico and In Vitro Approaches to Predict In Vivo Drug-Drug Interactions and ADMET/TOX Propertiesp. 307
In Vitro-In Vivo Correlations in Drug Discovery and Development: Concepts and Applications in Toxicologyp. 331
Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo Responsep. 353
Indexp. 383
Table of Contents provided by Ingram. All Rights Reserved.
J. Andrew Williams, PhD, is Director of Translations Oncology at Pfizer Oncology. Richard Lalonde, PharmD, is Vice President and Global Head of Clinical Pharmacology at Pfizer. Jeffrey Koup, PharmD, is a consultant for PKPD modeling and the owner of Lakeside PKPD, LLC. David D. Christ, PhD, is a consultant with SNC Partners LLC.


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