Written by leading investigators from academia and the pharmaceutical industry, this volume is a comprehensive, practical guide for all researchers involved in anticancer drug development. The book covers the entire field from preclinical research, through clinical trials, to licensure requirements in the United States and in the European Union. Chapters address drug discovery, preclinical models, drug measurement, delivery systems, Phase I trial design, and Phase II-III testing. The book provides state-of-the-art coverage of contemporary drug design concepts, in vitro models, new assay methodologies, good manufacturing practice criteria in the US and EU, and new methods for testing anticancer agents in humans
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Written by leading investigators from academia and the pharmaceutical industry, this volume is a comprehensive, practical guide for all researchers involved in anticancer drug development. The book covers the entire field from preclinical research, through clinical trials, to licensure requirements in the United States and in the European Union. Chapters address drug discovery, preclinical models, drug measurement, delivery systems, Phase I trial design, and Phase II-III testing. The book provides state-of-the-art coverage of contemporary drug design concepts, in vitro models, new assay methodologies, good manufacturing practice criteria in the US and EU, and new methods for testing anticancer agents in humans
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