Pharmacogenomics and Personalized Medicine

Leading experts from the pharmaceutical industry, the scientific community and the government provide guidance for conducting pharmacogenomic research from discovery to the market, while presenting a realistic perspective on the challenges in its application.

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.

Aids in pharmacogenomic study feasibility assessment and pharmaceutical business decision-making Contains the pharmacogenomics protocols, informed consent form, and applications in adverse drug reactions, drug discovery and clinical trials Describes the regulatory environment and labeling implications, marker selection, study design and statistical methods in pharmacogenomics research Explores the translation of biomarkers into clinical utility Provides pharmacogenomics applications in epilepsy, oncology, Alzheimer's Disease, psychiatric disorders, HIV diseases, cardio-vascular drugs, and in children, along with applications of rare and monogenic disorders Includes supplementary material: sn.pub/extras

Texte du rabat

With all of the multitude of challenges facing the pharmaceutical research and development process, the industry is actively exploring the relationships between human genetics and drug responsiveness, susceptibility to disease and disease severity. In Pharmacogenomics and Personalized Medicine, leading experts from the pharmaceutical industry, the scientific community and the government provide guidance for conducting pharmacogenomic research from discovery to the market, while also presenting a realistic perspective on the challenges, practicalities and obstacles in its application. Focusing on DNA data and associated analytical methodologies this volume includes a wide array of vital, cutting-edge research.

Comprehensive and timely, Pharmacogenomics and Personalized Medicine will assist novice and experienced investigators alike in the understanding of the current scientific challenges in applying pharmacogenomics to drug discovery and clinical development.

Contenu
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.