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 design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.
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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 Nutritional Biochemistry, 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.About the Author:
Dr. Tom Brody received his Ph.D. from the University of California at Berkeley in 1980 and has published several research articles in the areas of enzymology, metabolism and pharmacokinetics of folates and related amino acids. For his post-doctoral work, also at U.C. Berkeley, the author cloned, sequenced, and expressed an oncogene, and purified the encoded protein (xeroderma pigmentosum E; XPE). The XPE gene encodes a DNA repair protein. Later, he performed research on the structure of an antibody (natalizumab) used for treating multiple sclerosis. At an earlier time, he wrote two editions of Nutritional Biochemistry, published by Elsevier, Inc. The author is a registered patent agent.
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Book Description Academic Press, 2011. Hardcover. Book Condition: New. 1. Bookseller Inventory # DADAX0123919118
Book Description Academic Pr, 2011. Hardcover. Book Condition: Brand New. 1st edition. 672 pages. 9.50x7.75x1.50 inches. In Stock. Bookseller Inventory # zk0123919118
Book Description Academic Press 2011-11-25, 2011. Hardcover. Book Condition: New. 1. 0123919118. Bookseller Inventory # 673813
Book Description Academic Press, 2011. Hardcover. Book Condition: New. book. Bookseller Inventory # 0123919118
Book Description Academic Press, 2011. Hardcover. Book Condition: New. Bookseller Inventory # P110123919118