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Pharmacogenomics: Challenges and Opportunities in Therapeutic Implementation includes discussions and viewpoints from the academic, regulatory, pharmaceutical, clinical, soc… Read more
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This book is intended for scientists and clinicians interested in pharmacogenomics implementation in academic, research, medical and pharmaceutical industry settings. Relevant fields include pharmacology, pharmaceutical sciences, genetics, molecular biology and medicine. This book may also be used as a recommended textbook for pharmacy students and graduate-level students in health and pharmaceutical science programs.
Dedication
List of Contributors
Preface
Chapter 1. Principles of Pharmacogenomics: Pharmacokinetic, Pharmacodynamic, and Clinical Implications
Objectives
Introduction
Cytochrome P-450 Enzymes
Non-CYP-450 Drug Metabolizing Enzymes
Polymorphisms in Drug Transporter Genes
Drug Target Genes
Conclusion
Questions for Discussion
References
Chapter 2. Translating Pharmacogenomic Research to Therapeutic Potentials
Objectives
Introduction
Implementation of Biomarkers in Clinical Practice
Incorporating Pharmacogenomics into Drug Development
Conclusion
Questions for Discussion
References
Chapter 3. Governmental and Academic Efforts to Advance the Field of Pharmacogenomics
Objectives
Introduction
The Role of the National Institutes of Health
The Role of the Food and Drug Administration and Other International Government Agencies
Activities of Non-U.S. Agencies
Conclusion
Questions for Discussion
References
Chapter 4. Pharmacogenomics in Cancer Therapeutics
Objectives
Introduction
Role of Oncology Biomarkers
Concepts in Targeted Cancer Therapy
Oncology in the Postgenomic Era
Challenges in Drug Development and Cancer Trials
Seeking Pharmacogenomic Value
Questions for Discussion
References
Chapter 4A. A Look to the Future: Cancer Epigenetics
Learning Objectives
Introduction
Histone Modification
DNA Methylation
Noncoding RNA (ncRNA)
Conclusion
Questions for Discussion
References
Chapter 5. Pharmacogenetics in Cardiovascular Diseases
Objectives
Introduction
Pharmacogenomics of Antiplatelet Agents
Warfarin Pharmacogenomics
Other Genetic Contributions to Warfarin Dose Variability and Response
Trials and Tribulations of Pharmacogenomics of Agents Used to Treat Dyslipidemia
Pharmacogenomic Potential in Heart Failure
Genetic Influences of Drug-Induced Arrhythmia
Conclusion
Discussion Points
Discussion Questions
References
Chapter 5A. A Look to the Future: Cardiovascular Pharmacoepigenetics
Learning objectives
Introduction
Opportunities
Challenges
Conclusion
Questions for Discussion
References
Chapter 6. Pharmacogenomics in Psychiatric Disorders
Objectives
Introduction
Polymorphisms in Proteins that Affect Drug Concentrations
Polymorphisms in Proteins that Mediate Drug Response
Application of Pharmacogenomics in Psychiatry
Conclusion
Questions for Discussion
References
Chapter 6A. A Look to the Future: Epigenetics in Psychiatric Disorders and Treatment
Objectives
Nature and Nurture Both Contribute to the Etiologies of Psychiatric Disorders
Epigenetic Processes Are Likely to Contribute to the Biochemical Basis of “Nurture”
Epigenetic Dysfunction Has Been Linked to Psychiatric and Neurological Disorders
Epigenetic Processes May Be Critical to Treatment Response in Psychiatric Disorders
Epigenetic Variation of Genes Regulating Pharmacokinetic Processes Is Likely to Influence Treatment Response
Epigenetic Modifications of Drug Transporters
Epigenetics and Adverse Drug Reactions
Limitations of Epigenetic Biomarkers in Psychiatry
Conclusion
Questions for Discussion
References
Chapter 7. The Role of Pharmacogenomics in Diabetes, HIV Infection, and Pain Management
Objectives
Introduction
Diabetes Overview
Type 2 Diabetes Pharmacogenomics
Challenges and Opportunities of Pharmacogenomics in Diabetes
Pharmacogenomics and HIV
Pharmacogenomics and Pain Control
Conclusion
Questions for Discussion
References
Chapter 8. Molecular Approaches, Models, and Techniques in Pharmacogenomic Research and Development
Objectives
Introduction
Human Genetic Variation
Strategies in Pharmacogenomic Research and Development
Bioinformatic Resources for Pharmacogenomic Research and Development
Conclusion and Outlook
Acknowledgement
Questions for Discussion
References
Chapter 8A. Modeling the Pharmacogenetic Architecture of Drug Response
Objectives
Introduction
Genetic Mapping
Functional Genome-Wide Association Study
Discussion
Questions for Discussion
Acknowledgements
References
Chapter 9. Study Designs in Clinical Pharmacogenetic and Pharmacogenomic Research
Objectives
Introduction
Clinical Study Designs to Discover and Confirm the Impact of Human Pharmacogenetic Variation
Conclusion and Perspectives
Questions for Discussion
References
Chapter 9A. Incorporating Pharmacogenomics in Drug Development: A Perspective from Industry
Objectives
Introduction
Pharmacogenomics in Different Phases of Drug Development
Drug Target Screening and Identification
Preclinical Animal Toxicology Studies
Phase I Studies
Phase II and III Studies
Phase IV Studies
Challenges in Applying Pharmacogenomics in Drug Development
Future Perspective
Discussion Questions
References
Chapter 10. The Importance of Ethnicity Definitions and Pharmacogenomics in Ethnobridging
Objectives
Introduction
Ethnicity
Ethnic Factors Affecting Drug Response
Acceptability of Foreign Clinical Data
Conclusion
Discussion Questions
References
Chapter 11. Beyond ELSIs: Where to from Here? From “Regulating” to Anticipating and Shaping the Innovation Trajectory in Personalized Medicine
Objectives
Pharmacogenetics: An Old Science that Stood the Test of Time
Pharmacogenomics: An Old Science Becomes Large-Scale and Global
Rethinking Bioethics in the Twenty-First Century
Beyond Classic ELSIs
An Invitation to Reflexive and Global Bioethics
Conclusion
Discussion Questions
Acknowledgments
References
Chapter 12. Pharmacoeconomics of Pharmacogenetics within the Context of General Health Technology Assessments
Objectives
Introduction
Criteria for Decision Making
Pharmacoeconomics/Health Economics within the HTA Context
Process
Conclusion
Questions for Discussion
References
Appendix: Case Study in the Netherlands
Appendix 1 References
Chapter 13. Integrating Genomics into Pharmacy Education and Practice: Pharmacogenomics Is Not Enough
Objectives
Introduction: The Case for Genomics
Technology as the Driver of Genomic Science
The Critical Gap in Pharmacy Education
Educational Competencies
Conclusion
Questions for Discussion
References
Color Plates
Index
YL
LC