Description
A hands-on guidebook that integrates the most practical aspects of clinical trial design with important content on laboratory studies of human data, patient safety, regulatory requirements and much more
About the Author
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.
Book Information
ISBN 9780128042175
Author Tom Brody
Format Hardback
Page Count 896
Imprint Academic Press Inc
Publisher Elsevier Science Publishing Co Inc
Weight(grams) 2740g