Predictive Approaches in Drug Discovery and Development
Biomarkers and in Vitro / In Vivo Correlations
Herausgegeben von Williams, J. Andrew; Lalonde, Richard; Koup, Jeffrey R.; Christ, David D.; Ekins, Sean
Predictive Approaches in Drug Discovery and Development
Biomarkers and in Vitro / In Vivo Correlations
Herausgegeben von Williams, J. Andrew; Lalonde, Richard; Koup, Jeffrey R.; Christ, David D.; Ekins, Sean
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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.
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- Produktdetails
- Wiley Series on Technologies for the Pharmaceutical Industry
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 416
- Erscheinungstermin: 10. April 2012
- Englisch
- Abmessung: 240mm x 161mm x 26mm
- Gewicht: 716g
- ISBN-13: 9780470170830
- ISBN-10: 0470170832
- Artikelnr.: 34440683
- Wiley Series on Technologies for the Pharmaceutical Industry
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 416
- Erscheinungstermin: 10. April 2012
- Englisch
- Abmessung: 240mm x 161mm x 26mm
- Gewicht: 716g
- ISBN-13: 9780470170830
- ISBN-10: 0470170832
- Artikelnr.: 34440683
DISCOVERY 1 1 The Importance of Biomarkers in Translational Medicine 3
Joseph C. Fleishaker 2 Validation of Biochemical Biomarker Assays used in
Drug Discovery and Development: A Review of Challenges and Solutions 23
Gabriella Szekely-Klepser and Scott Fountain 3 Proteomic Methods to Develop
Protein Biomarkers 49 Ruth A. VanBogelen and Diane Alessi 4 Overview of
Metabolomics Basics 79 Qiuwei Xu and William H. Schaefer PART II CLINICAL
APPLICATION OF BIOMARKERS 139 5 Vascular Biomarkers and Imaging Studies 141
Karin Potthoff, Ulrike Fiedler, and Joachim Drevs 6 Cardiovascular
Biomarkers as Examples of Success and Failure in Predicting Safety in
Humans 163 Simon Authier, Michael K. Pugsley, Eric Troncy, and Michael J.
Curtis 7 The Use of Molecular Imaging for Receptor Occupancy Decision
Making in Drug Development 189 Ralph Paul Maguire 8 Biosensors for Clinical
Biomarkers 203 Sara Tombelli and Marco Mascini PART III REGULATORY
PERSPECTIVES 229 9 Regulatory Perspectives on Biomarker Development 231
Rajanikanth Madabushi, Lawrence Lesko, and Janet Woodcock 10 Perspectives
from the European Regulatory Authorities 255 Ian Hudson 11 Use of Biomarker
in Drug Development--Japanese Perspectives 269 Yoshiaki Uyama, Akihiro
Ishiguro, Harumasa Nakamura,and Satoshi Toyoshima PART IV PREDICTING IN
VIVO 289 12 In Vitro-In Vivo Correlations of Hepatic Drug Clearance 291 R.
Scott Obach 13 The Potential of In Silico and In Vitro Approaches to
Predict In Vivo Drug-Drug Interactions and ADMET/TOX Properties 307 Kenneth
Bachmann and Sean Ekins 14 In Vitro-In Vivo Correlations in Drug Discovery
and Development: Concepts and Applications in Toxicology 331 Rex Denton,
Kimberly Brannen, and Bruce D. Car 15 Assessing the Potential for Induction
of Cytochrome P450 Enzymes and Predicting the In Vivo Response 353 Jiunn H.
Lin INDEX 383
DISCOVERY 1 1 The Importance of Biomarkers in Translational Medicine 3
Joseph C. Fleishaker 2 Validation of Biochemical Biomarker Assays used in
Drug Discovery and Development: A Review of Challenges and Solutions 23
Gabriella Szekely-Klepser and Scott Fountain 3 Proteomic Methods to Develop
Protein Biomarkers 49 Ruth A. VanBogelen and Diane Alessi 4 Overview of
Metabolomics Basics 79 Qiuwei Xu and William H. Schaefer PART II CLINICAL
APPLICATION OF BIOMARKERS 139 5 Vascular Biomarkers and Imaging Studies 141
Karin Potthoff, Ulrike Fiedler, and Joachim Drevs 6 Cardiovascular
Biomarkers as Examples of Success and Failure in Predicting Safety in
Humans 163 Simon Authier, Michael K. Pugsley, Eric Troncy, and Michael J.
Curtis 7 The Use of Molecular Imaging for Receptor Occupancy Decision
Making in Drug Development 189 Ralph Paul Maguire 8 Biosensors for Clinical
Biomarkers 203 Sara Tombelli and Marco Mascini PART III REGULATORY
PERSPECTIVES 229 9 Regulatory Perspectives on Biomarker Development 231
Rajanikanth Madabushi, Lawrence Lesko, and Janet Woodcock 10 Perspectives
from the European Regulatory Authorities 255 Ian Hudson 11 Use of Biomarker
in Drug Development--Japanese Perspectives 269 Yoshiaki Uyama, Akihiro
Ishiguro, Harumasa Nakamura,and Satoshi Toyoshima PART IV PREDICTING IN
VIVO 289 12 In Vitro-In Vivo Correlations of Hepatic Drug Clearance 291 R.
Scott Obach 13 The Potential of In Silico and In Vitro Approaches to
Predict In Vivo Drug-Drug Interactions and ADMET/TOX Properties 307 Kenneth
Bachmann and Sean Ekins 14 In Vitro-In Vivo Correlations in Drug Discovery
and Development: Concepts and Applications in Toxicology 331 Rex Denton,
Kimberly Brannen, and Bruce D. Car 15 Assessing the Potential for Induction
of Cytochrome P450 Enzymes and Predicting the In Vivo Response 353 Jiunn H.
Lin INDEX 383