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Doody's Review ServiceReviewer: Thomas L. Pazdernik, PhD (University of Kansas Medical Center)
Description: Translational research is a current buzz word that deals with bringing bench research to the bedside. This book in the Wiley Series on Technologies for the Pharmaceutical Industry focuses on the use of in vitro and in vivo biomarkers to facilitate drug discovery and development.
Purpose: The editors' objective is to provide a critical compilation of the most important aspects of the use of in vitro and in vivo biomarkers to facilitate translating basic pharmacology and drug effects into clinical utility and regulatory acceptance. They have done a marvelous job of bringing these correlations together.
Audience: This book is designed to be of value to all those in academia or the pharmaceutical industry who are involved in the process of new drug discovery all the way from concepts, "go-to-no-go" decision processes, and regulatory aspects.
Features: Part I deals with the use of biomarkers in drug discovery including importance, validation, and proteomic and metabolomics methods. Part II focuses on clinical applications of biomarkers including vascular biomarkers and imaging, success and failure in the prediction human safety via cardiovascular biomarkers, the use of molecular imaging for receptor occupancy for decision making in drug discovery, and the use of biosensors as clinical markers. Part III deals with regulatory perspectives and includes chapters providing European and Japanese perspectives. Part IV covers predicting responses in vivo such as in vitro/in vivo correlations of hepatic drug clearance, the potential of a combination of in silico and in vitro approaches to predict in vivo drug-drug interactions, pharmacokinetics, and toxicity; and the use of in vitro/in vivo correlations for developing concepts and applications in toxicology, plus assessing the potential for induction of cytochrome p450 enzymes and predicting in vivo metabolism.
Assessment: The ability to correlate in vitro and in vivo biomarker information in the process of drug discovery and development lies at the heart of translational research. The goal is to rapidly translate basic discoveries into clinical applications. This book provides state-of-the-art information on this exciting new research approach.