Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development
(Sprache: Englisch)
Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development gathers diverse experts to present state of the art guidance and application of histopathology in drug development settings ranging from discovery research to human clinical...
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Klappentext zu „Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development “
Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development gathers diverse experts to present state of the art guidance and application of histopathology in drug development settings ranging from discovery research to human clinical trials. While many current applications of quantitative histology and molecular pathology in the biopharmaceutical industry are focused on oncology, this volume in addition explores non-oncologic disease areas including nonalcoholic steatohepatitis, arthritis, celiac disease, myeloproliferative disorders, neurology, and wound healing. The authors write from years of experience in diagnostic practice and pharmaceutical drug development, aiming to educate pharmaceutical and academic scientists how to best use tissue to diagnose disease and improve the process of drug development. As part of the Methods in Pharmacology and Toxicology series, this volume is designed to provide wisdom and examples that others can follow and apply as part of drug development.Comprehensive and practical, Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development will inform and enlighten both tissue-focused and non-tissue-focused drug development professionals about better use and interpretation of the multidimensional data contained in a tissue biopsy.
Inhaltsverzeichnis zu „Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development “
Part I: Current Perspectives on the Pathology Discipline in the Pharma Industry1. Histopathology: A Canvas and Landscape of Disease in Drug and Diagnostic Development
Keith A. Wharton, Jr.
2. A Field Guide to Homo morphologicus for Biomedical Scientists, Or How to Convey an Understanding of Pathology to Scientists in a Biopharma Enterprise
Humphrey Gardner
3. Outsourcing Tissue Histopathology Investigations in Support of Clinical Trials for Novel Therapeutics: Considerations and Perspectives
Keith A. Wharton, Jr., Benjamin H. Lee, Pierre Moulin, Dale Mongeon, Rainer Hillenbrand, Arkady Gusev, Bin Ye, and Xiaoyu Jiang
4. Histopathology in Mouse Models of Rheumatoid Arthritis
Patrick Caplazi and Lauri Diehl
Part II: Current Directions in Histopathology for Drug Development, Involving Tissue Image Analysis
5. Markers Used for Visualization and Quantification of Blood Vessels and Lymphatic Vessels
Mohamed E. Salama, David A. Eberhard, and Steven J. Potts
6. Practical Approaches to Microvessel Analysis: Hotspots, Microvessel Density, and Vessel Proximity
Steven J. Potts, David A. Eberhard, and Mohamed E. Salama
7. Quantitative Histopathology and Alternative Approaches to Assessment of Fibrosis for Drug Development in Hepatitis C and Nonalcoholic Steatohepatitis
Steven J. Potts and Johanna K. DiStefano
8. Stereology and Computer-Based Image Analysis Quantifies Heterogeneity and Improves Reproducibility for Grading Reticulin in Myeloproliferative Neoplasms
Mohamed E. Salama, Erik Hagendorn, Sherrie L. Perkins, Jeff Kutok, Etman A, Josef T. Prchal, and Steven J. Potts
9. Image Analysis Tools for Quantification of Spinal Motor Neuron Subtype Identities
Mirza Peljto and Hynek Wichterle
10. Development of a Tissue Image Analysis Algorithm for Celiac Drug Development
Erik Hagendorn, Christa Whitney-Miller, Aaron Huber, and Steven J. Potts
11. Quantitative Histopathology for Evaluation of In Vivo Biocompatibility
... mehr
Associated with Biomedical Implants
Robert B. Diller, Robert G. Audet, and Robert S. Kellar
12. Quantitative Histomorphometry and Quantitative Polymerase Chain Reaction (PCR) as Assessment Tools for Product Development
Robert G. Audet, Robert B. Diller, and Robert S. Kellar
Part III: Current Directions in Histopathology for Drug Development, Involving Molecular Histopathology: In Situ Hybridization
13. Measuring the Messenger: RNA Histology in Formalin Fixed Tissues
Steven J. Potts, Mirza Peljto, Brian Laffin, Mahipal Suraneni, and Joseph S. Krueger
14. Algorithm-Driven Image Analysis Solutions for RNA ISH Quantification in Human Clinical Tissues
Mirza Peljto, Joseph S. Krueger, Nicholas D. Landis, Mahipal Suraneni, Brian Laffin, G. David Young, and Steven J. Potts
15. Solid Tissue-Based DNA Analysis by FISH in Research and Molecular Diagnostics
Marcus Otte
Part III: Current Directions in Histopathology for Drug Development, Involving Molecular Histopathology: Sequencing and Genomics
16. Preanalytic Considerations for Molecular Genomic Analyses of Tissue
Maureen Cronin
17. Next Generation Sequencing (NGS) in Anatomic Pathology Discovery and Practice
Matthew J. McGinniss, David A. Eberhard, and Keith A. Wharton, Jr.
Part IV: Current Directions in Histopathology for Drug Development, Involving Companion Diagnostics
18. The Impact of Pre-Analytic Variables on Tissue Quality from Clinical Samples Collected in a Routine Clinical Setting: Implications for Diagnostic Evaluation, Drug Discovery, and Translational Research
David G. Hicks
19. Adapting HER2 Testing for a Different Organ: New Wine in Old Wineskins
Michael D. Lunt and Christa L. Whitney-Miller
20. Tissue-Based Companion Diagnostics: Development of IHC Assays from an Industry Perspective
Miu Chau and Jon Askaa
21. Development of Tissue-Based Companion Diagnostics: The Relationship Between the Pharmaceutical Company, Diagnostic Partner, and the Biomarker Laboratory
Mark Kockx, Stefanie de Schepper, and Christopher Ung
22. Navigating Regulatory Approval for Tissue-Based Companion Diagnostics
Joseph S. Krueger, Holger Lange, G. David Young, and Steven J. Potts
23. Implementing a Multi-Analyte Immunohistochemistry Panel into a Drug Development Program
Carla Heise, Pierre Brousset, Tommy Fu, David A. Eberhard, Graham W. Slack, Camille Laurent, and Randy D. Gascoyne
24. Cutpoint Analysis and Related Statistical Methods in Digital Pathology and Companion Diagnostics
Joshua C. Black, Mahipal V. Suraneni, and Steven J. Potts
Robert B. Diller, Robert G. Audet, and Robert S. Kellar
12. Quantitative Histomorphometry and Quantitative Polymerase Chain Reaction (PCR) as Assessment Tools for Product Development
Robert G. Audet, Robert B. Diller, and Robert S. Kellar
Part III: Current Directions in Histopathology for Drug Development, Involving Molecular Histopathology: In Situ Hybridization
13. Measuring the Messenger: RNA Histology in Formalin Fixed Tissues
Steven J. Potts, Mirza Peljto, Brian Laffin, Mahipal Suraneni, and Joseph S. Krueger
14. Algorithm-Driven Image Analysis Solutions for RNA ISH Quantification in Human Clinical Tissues
Mirza Peljto, Joseph S. Krueger, Nicholas D. Landis, Mahipal Suraneni, Brian Laffin, G. David Young, and Steven J. Potts
15. Solid Tissue-Based DNA Analysis by FISH in Research and Molecular Diagnostics
Marcus Otte
Part III: Current Directions in Histopathology for Drug Development, Involving Molecular Histopathology: Sequencing and Genomics
16. Preanalytic Considerations for Molecular Genomic Analyses of Tissue
Maureen Cronin
17. Next Generation Sequencing (NGS) in Anatomic Pathology Discovery and Practice
Matthew J. McGinniss, David A. Eberhard, and Keith A. Wharton, Jr.
Part IV: Current Directions in Histopathology for Drug Development, Involving Companion Diagnostics
18. The Impact of Pre-Analytic Variables on Tissue Quality from Clinical Samples Collected in a Routine Clinical Setting: Implications for Diagnostic Evaluation, Drug Discovery, and Translational Research
David G. Hicks
19. Adapting HER2 Testing for a Different Organ: New Wine in Old Wineskins
Michael D. Lunt and Christa L. Whitney-Miller
20. Tissue-Based Companion Diagnostics: Development of IHC Assays from an Industry Perspective
Miu Chau and Jon Askaa
21. Development of Tissue-Based Companion Diagnostics: The Relationship Between the Pharmaceutical Company, Diagnostic Partner, and the Biomarker Laboratory
Mark Kockx, Stefanie de Schepper, and Christopher Ung
22. Navigating Regulatory Approval for Tissue-Based Companion Diagnostics
Joseph S. Krueger, Holger Lange, G. David Young, and Steven J. Potts
23. Implementing a Multi-Analyte Immunohistochemistry Panel into a Drug Development Program
Carla Heise, Pierre Brousset, Tommy Fu, David A. Eberhard, Graham W. Slack, Camille Laurent, and Randy D. Gascoyne
24. Cutpoint Analysis and Related Statistical Methods in Digital Pathology and Companion Diagnostics
Joshua C. Black, Mahipal V. Suraneni, and Steven J. Potts
... weniger
Bibliographische Angaben
- 2015, 2015, XVIII, 375 Seiten, 37 farbige Abbildungen, Maße: 17,8 x 25,4 cm, Gebunden, Englisch
- Herausgegeben: Steven J. Potts, David A. Eberhard, Keith A. Wharton
- Verlag: Springer, Berlin
- ISBN-10: 1493926802
- ISBN-13: 9781493926800
- Erscheinungsdatum: 15.06.2015
Sprache:
Englisch
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