Clinical Trials

Clinical Trials

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Clinical Trials by Tom Brody Rigel Pharmaceuticals Primegen Biotech Regeneron Pharmaceuticals And Biogen Idec )

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.
Dr. Tom Brody received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at University of Wisconsin-Madison and also at U.C. Berkeley. His 20 research publications concern the metabolism and pharmacology of folates, cloning an anti-cancer gene (XPE gene), and the structure of an antibody (natalizumab) used for treating multiple sclerosis. The author has 15 years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Elan Pharmaceuticals, and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C. At an earlier time, he wrote two editions of Clinical Trials, published by Elsevier, Inc. The author has 16 years of training and experience in the Code of Federal regulations, as it applies to pharmaceuticals and clinical trial design.
SKU Nicht verfügbar
ISBN 13 9780128042175
ISBN 10 0128042176
Titel Clinical Trials
Autor Tom Brody Rigel Pharmaceuticals Primegen Biotech Regeneron Pharmaceuticals And Biogen Idec )
Buchzustand Nicht verfügbar
Bindungsart Hardback
Verlag Elsevier Science Publishing Co Inc
Erscheinungsjahr 2016-03-14
Seitenanzahl 896
Hinweis auf dem Einband Die Abbildung des Buches dient nur Illustrationszwecken, die tatsächliche Bindung, das Cover und die Auflage können sich davon unterscheiden.
Hinweis Nicht verfügbar