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concerns within the pharmaceutical industry about generating data that might be difficult to interpret in a regulated environment. There is also a growing apprec- tion for the challenges in translating this new information into clinical utility, including scientific, commercial, ethical, and policy challenges. Pharmacogenomics and Personalized Medicine, which is part of the Methods in Pharmacology and Toxicology series, comprises chapters on selected aspects of pharmacogenomics and personalized medicine. Our overall intent is to assist both novice and experienced investigators in understanding the current scientific ch- lenges in applying PGx to discovery and clinical development and in making app- priate decisions to engage in and interpret PGx research. Designed to share the experiences of leading experts in the field, the book is a useful guide for conducting PGx research--from discovery to the market, but we also aim to present a realistic perspective on the challenges, practicalities, and obstacles in applying pharmac- enomics. Generally, the book avoids statements such as "Pharmacogenomics is going to revolutionize the practice of medicine," which are neither realistic nor particularly useful to anyone. The book presents an industry perspective on the implementation of PGx in research and development, in drug discovery, and in clinical trials, including rec- mendations for a systematic approach for assessing the feasibility and added value of PGx studies in clinical trials.
List of contents
Challenges, Opportunities, and Evolving Landscapes in Pharmacogenomics and Personalized Medicine.- Implementation of Pharmacogenomic Sample Collection in Clinical Trials.- Pharmacogenomics.- Applications of Pharmacogenomics in Drug Discovery.- Applications of Pharmacogenomics in Clinical Trials.- Pharmacogenomics Applications in Drug Metabolism.- The Genetics of Adverse Drug Reactions.- Strategies and Resources for Marker Selection and Genotyping in Genetic Association Studies.- Study Design and Statistical Issues in Pharmacogenetics Research.- Holy SNP, Batman!.- Predictive Biomarker Classifiers in the Design of Pivotal Clinical Trials.- Translation of Biomarkers into Clinical Utility.- Pharmacogenomic Study Feasibility Assessment and Pharmaceutical Business Decision-Making.- Co-Development of Drugs and Pharmacogenomics-Based Diagnostics in Oncology.- Pharmacogenomics Applications in Epilepsy Chantal Depondt.- Pharmacogenomics in Alzheimer's Disease.- Pharmacogenomics Applications in Psychiatric Disorders.- Pharmacogenomics in HIV Disease.- Pharmacogenomics and Cardiovascular Drugs.- Pharmacogenomic Applications in Children.- Pharmacogenomics of Rare and Monogenic Disorders.
Summary
concerns within the pharmaceutical industry about generating data that might be difficult to interpret in a regulated environment. There is also a growing apprec- tion for the challenges in translating this new information into clinical utility, including scientific, commercial, ethical, and policy challenges. Pharmacogenomics and Personalized Medicine, which is part of the Methods in Pharmacology and Toxicology series, comprises chapters on selected aspects of pharmacogenomics and personalized medicine. Our overall intent is to assist both novice and experienced investigators in understanding the current scientific ch- lenges in applying PGx to discovery and clinical development and in making app- priate decisions to engage in and interpret PGx research. Designed to share the experiences of leading experts in the field, the book is a useful guide for conducting PGx research--from discovery to the market, but we also aim to present a realistic perspective on the challenges, practicalities, and obstacles in applying pharmac- enomics. Generally, the book avoids statements such as “Pharmacogenomics is going to revolutionize the practice of medicine,” which are neither realistic nor particularly useful to anyone. The book presents an industry perspective on the implementation of PGx in research and development, in drug discovery, and in clinical trials, including rec- mendations for a systematic approach for assessing the feasibility and added value of PGx studies in clinical trials.
Additional text
From the reviews:
"The purpose is to provide a practical and integrative view of the application of pharmacogenomics to personalized medicine. … the information is valuable for scientists in academic, industrial, and healthcare areas who are striving to transform the current practice of medicine into personalized medicine. … this one provides the most comprehensive discussion on how to apply pharmacogenomics to attain greater success in bringing personalized medicine to clinical practice." (Xiaobo Zhong, Doody’s Review Service, January, 2009)
Report
From the reviews:
"The purpose is to provide a practical and integrative view of the application of pharmacogenomics to personalized medicine. ... the information is valuable for scientists in academic, industrial, and healthcare areas who are striving to transform the current practice of medicine into personalized medicine. ... this one provides the most comprehensive discussion on how to apply pharmacogenomics to attain greater success in bringing personalized medicine to clinical practice." (Xiaobo Zhong, Doody's Review Service, January, 2009)
