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|a Translational medicine and drug discovery /
|c edited by Bruce H. Littman, Rajesh Krishna.
|
264 |
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1 |
|a Cambridge :
|b Cambridge University Press,
|c 2011.
|
264 |
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|c ©2011
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300 |
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|a 1 online resource (xx, 361 pages) :
|b illustrations
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|a text
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|a online resource
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|a Includes bibliographical references and index.
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|a "This book, edited by two leaders known for driving innovation in the field, focuses on the new discipline of translational medicine as it pertains to drug discovery and development within the pharmaceutical and biotechnology industries. Translational medicine seeks to translate biological and molecular knowledge of disease and how drugs work into innovative strategies that reduce the cost and increase the speed of delivering newmedicines for patients. This book describes these general strategies, biomarker development, imaging tools, translational human models, and examples of their application to real-life drug discovery and development. The latest thinking is presented by researchers from many of the world's leading pharmaceutical companies, including Pfizer, Merck, Eli Lilly, Abbott, and Novartis, as well as from academic institutions and public-private partnerships that support translational research. This book is essential for anyone interested in translational medicine from a variety of backgrounds (university institutes, medical schools, and pharmaceutical companies) in addition to drug development researchers and decision makers."--Publisher's description.
|
505 |
0 |
0 |
|g SECTION I:
|t Translational Medicine: History, Principles, and Application in Drug Development --
|g 1.
|t Translational Medicine: Definition, History, and Strategies /
|r Bruce H. Littman --
|g 2.
|t Translational Medicine and Its Impact on Diabetes Drug Development /
|r Roberto A. Calle and Ann E. Taylor --
|g 3.
|t Challenges in Atherosclerosis /
|r John S. Millar --
|g 4.
|t Obesity: New Mechanisms and Translational Paradigms /
|r Gregory Gaich and David E. Moller --
|g 5.
|t Bone Disorders: Translational Medicine Case Studies /
|r S. Aubrey Stoch --
|g 6.
|t Case Studies in Neuroscience: Unique Challenges and Examples Gerard /
|r J. Marek --
|g 7.
|t Translational Medicine in Oncology /
|r Dominic G. Spinella.
|
505 |
8 |
0 |
|g SECTION II:
|t Biomarkers and Public-Private Partnerships --
|g 8.
|t Biomarker Validation and Application in Early Drug Development: Idea to Proof of Concept /
|r Pfizer Global Research and Development --
|g 9.
|t Imaging Biomarkers in Drug Development: Case Studies /
|r Johannes T. Tauscher and Adam J. Schwarz --
|g 10.
|t European New Safe and Innovative Medicines Initiatives: History and Progress (through December 2009) /
|r Ole J. Bjerrum and Hans H. Linden --
|g 11.
|t Critical Path Institute and the Predictive Safety Testing Consortium /
|r Elizabeth Gribble Walker --
|g 12.
|t The Biomarkers Consortium: Facilitating the Development and Qualification of Novel Biomarkers Through a Precompetitive Public-Private Partnership /
|r David Wholley and David B. Lee.
|
505 |
8 |
0 |
|g SECTION III:
|t Future Directions --
|g 13.
|t Improving the Quality and Productivity of Pharmacometric Modeling and Simulation Activities: the Foundation for Model-Based Drug Development /
|r Thaddeus H. Grasela, Jill Fiedler-Kelly, and Robert Slusser --
|g 14.
|t Embracing Change: a Pharmaceutical Industry Guide to the 21st Century /
|r Mervyn Turner.
|
588 |
0 |
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|a Print version record and online resource.
|
546 |
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|a English.
|
590 |
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|a Knovel
|b ACADEMIC - Pharmaceuticals, Cosmetics & Toiletries
|
650 |
|
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|a Drug development.
|
650 |
|
0 |
|a Molecular pharmacology.
|
650 |
2 |
2 |
|a Translational Research, Biomedical
|x methods
|
650 |
1 |
2 |
|a Drug Discovery
|
650 |
|
6 |
|a Médicaments
|x Développement.
|
650 |
|
6 |
|a Pharmacologie moléculaire.
|
650 |
|
7 |
|a MEDICAL
|x Drug Guides.
|2 bisacsh
|
650 |
|
7 |
|a MEDICAL
|x Nursing
|x Pharmacology.
|2 bisacsh
|
650 |
|
7 |
|a MEDICAL
|x Pharmacology.
|2 bisacsh
|
650 |
|
7 |
|a MEDICAL
|x Pharmacy.
|2 bisacsh
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650 |
|
7 |
|a Drug development
|2 fast
|
650 |
|
7 |
|a Molecular pharmacology
|2 fast
|
700 |
1 |
|
|a Littman, Bruce H.,
|d 1944-
|e editor.
|
700 |
1 |
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|a Krishna, Rajesh,
|e editor.
|
776 |
0 |
8 |
|i Print version:
|t Translational medicine and drug discovery.
|d New York : Cambridge University Press, 2011
|z 9780521886451
|w (DLC) 2010037116
|w (OCoLC)660509871
|
856 |
4 |
0 |
|u https://appknovel.uam.elogim.com/kn/resources/kpTMDD0001/toc
|z Texto completo
|
880 |
0 |
|
|6 505-00/(S
|a Cover -- Title -- Copyright -- Contents -- Contributors -- Preface -- Translational Medicine and Drug Discovery -- Section I Translational Medicine: History, Principles, and Application in Drug Development -- 1 Translational Medicine: Definition, History, and Strategies -- 1.1. Biomarkers in Drug Development: A Common Understanding -- 1.2. Pharmacology: Testing the Target (POM) -- 1.3. Study Design Considerations for POM -- 1.3.1. Population -- 1.3.2. Risk -- 1.3.3. Feasibility -- 1.3.4. Endpoints -- 1.3.5. PK-PD and PD-PD Models -- 1.4. Confirming the Hypothesis That a Drug Target (Mechanism of Action) Will Be Efficacious (POC) -- 1.5. Study Design Considerations for POC -- 1.5.1. Population -- 1.5.2. Efficacy Endpoints -- 1.5.3. Dose Selection -- 1.5.4. Cost, Speed, and Risk -- 1.5.5. Multiple Indications (Serial or Parallel) -- 1.6. Human Indications Screening -- 1.6.1. Expl-IND Application -- 1.6.2. Low Cost Attrition and Portfolio Economics -- 1.7. Commercial Profile and Translational Medicine -- 1.7.1. Impact on Survival -- 1.7.2. Impact on Decision Making -- 1.7.3. Translational Medicine and the Personalized Medicine Option -- 1.8. Conclusion -- 2 Translational Medicine and Its Impact on Diabetes Drug Development -- 2.1. Introduction -- 2.2. Primary Challenges -- 2.2.1. Efficacy -- 2.2.1.1. Glucose Lowering -- 2.2.1.1.1. Additional Benefits Beyond Glucose Lowering -- 2.2.1.1.1.1. Weight Loss -- 2.2.1.1.1.2. Cardiovascular Benefit -- 2.2.1.1.1.3. β-Cell Preservation -- 2.2.2. Safety -- 2.2.2.1. Cardiovascular -- 2.2.2.2. Hypoglycemia -- 2.3. Case Studies -- 2.3.1. Case Study #1: Development of DPP-4i -- 2.3.2. Case Study #2: Development of 11-βHydroxysteroid Dehydrogenase Type 1 Inhibitors -- 2.3.3. Case Study #3: Effect of Weight Loss on HbA1c -- 2.4. Conclusions -- 2.5. Acknowledgments -- 3 Challenges in Atherosclerosis.
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