Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and Ich Guidelines

by Tom Brody

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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study...

Format:Hardcover

Language:English

ISBN:0123919118

ISBN13:9780123919113

Release Date:November 2011

Publisher:Academic Press

Length:638 Pages

Weight:3.00 lbs.

Dimensions:1.5" x 7.5" x 9.3"

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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and Ich Guidelines

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