Overview

The Future of Clinical Research and Health Care: From Empirical to Precision MedicineClinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease TreatmentThe first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subsequent chapters examine the statistical considerations in applying a personalized medicine approach, including multiplicity in pharmacogenomics. The last chapter assesses the regulatory issues involved in using biomarkers. Improve Patient Care and Reduce Costs and Side EffectsDespite the vast amount of literature on biomarkers, there is no comprehensive book that integrates the clinical and statistical components. This book is one of the first to incorporate both the clinical and statistical aspects of biomarkers in the personalized medicine paradigm. Covering a wide spectrum of personalized medicine-related topics, it presents state-of-the-art techniques for advancing the application of biomarkers in drug discovery and development.

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9781466593862

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The editors of this book successfully maintain a focus on those biomarkers used in the development of new drugs ... . Any statistician or scientist who seeks to wield pharmaceutical biomarkers on the quest for personalized medical certainty will find this book a timely and useful reference on a most important and fastest evolving subject. -Journal of Biopharmaceutical Statistics, 2015

The editors of this book successfully maintain a focus on those biomarkers used in the development of new drugs ... . Any statistician or scientist who seeks to wield pharmaceutical biomarkers on the quest for personalized medical certainty will find this book a timely and useful reference on a most important and fastest evolving subject. -Journal of Biopharmaceutical Statistics, 2015

"""The editors of this book successfully maintain a focus on those biomarkers used in the development of new drugs ... . Any statistician or scientist who seeks to wield pharmaceutical biomarkers on the quest for personalized medical certainty will find this book a timely and useful reference on a most important and fastest evolving subject."" -Journal of Biopharmaceutical Statistics, 2015"

Author Information

Claudio Carini, Sandeep Menon, Mark Chang

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