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FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions
Download PDF FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions
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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.
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Product details
Paperback: 670 pages
Publisher: Academic Press; 1 edition (December 15, 2017)
Language: English
ISBN-10: 0128146478
ISBN-13: 978-0128146477
Product Dimensions:
7.5 x 9.2 inches
Shipping Weight: 3.1 pounds (View shipping rates and policies)
Average Customer Review:
5.0 out of 5 stars
1 customer review
Amazon Best Sellers Rank:
#883,484 in Books (See Top 100 in Books)
Very detailed book covering practical aspects of IND and BLA development with plenty of examples
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