Predictive Approaches in Drug Discovery and

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 discussed.

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.

Preface	p. xi
Acknowledgments	p. xiii
Contributors	p. xv
Biomarkers in Drug Discovery	p. 1
The Importance of Biomarkers in Translational Medicine	p. 3
Validation of Biochemical Biomarker Assays used in Drug Discovery and Development: A Review of Challenges and Solutions	p. 23
Proteomic Methods to Develop Protein Biomarkers	p. 49
Overview of Metabolomics Basics	p. 79
Clinical Application of Biomarkers	p. 139
Vascular Biomarkers and Imaging Studies	p. 141
Cardiovascular Biomarkers as Examples of Success and Failure in Predicting Safety in Humans	p. 163
The Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug Development	p. 189
Biosensors for Clinical Biomarkers	p. 203
Regulatory Perspectives	p. 229
Regulatory Perspectives on Biomarker Development	p. 231
Perspectives from the European Regulatory Authorities	p. 255
Use of Biomarker in Drug Development-Japanese Perspectives	p. 269
Predicting in VIVO	p. 289
In Vitro-In Vivo Correlations of Hepatic Drug Clearance	p. 291
The Potential of In Silico and In Vitro Approaches to Predict In Vivo Drug-Drug Interactions and ADMET/TOX Properties	p. 307
In Vitro-In Vivo Correlations in Drug Discovery and Development: Concepts and Applications in Toxicology	p. 331
Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo Response	p. 353
Index	p. 383
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Predictive Approaches in Drug Discovery and Development Biomarkers and In Vitro / In Vivo Correlations

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