Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines Hardcover – November 25, 2011
Author: Tom Brody PhD University of California at Berkeley | Language: English | ISBN: 0123919118 | Format: PDF, EPUB
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines – November 25, 2011
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Review
".A solid guide to designing clinical trials for medical scientists, especially those working in oncology, immune disease, and infectious disease.Three chapters address quality-of-life topics." -Selected for The First Clinical Research Bookshelf, "Essential Reading for Clinical Research Professionals," Journal of Clinical Research Best Practices, September 2012, Vol. 8, No. 9
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.
Download latest books on mediafire and other links compilation Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines – November 25, 2011
- Hardcover: 672 pages
- Publisher: Academic Press; 1 edition (November 25, 2011)
- Language: English
- ISBN-10: 0123919118
- ISBN-13: 978-0123919113
- Product Dimensions: 1.5 x 7.6 x 9 inches
- Shipping Weight: 3.4 pounds (View shipping rates and policies)
- Amazon Best Sellers Rank: #538,179 in Books (See Top 100 in Books)
- #31 in Books > Medical Books > Pharmacology > Clinical
The following is a quotation from a review that was published in Journal of Clinical Research Best Practices, Vol. 8, Sept. 2012. The author of this review is Norman M. Goldfarb.
The published review is as follows, and I quote:
"Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines, is a solid guide to designing clinical trials for medical scientists, especially those working in oncology, immune disease, and infectious disease. The statistical chapters are brief and include very few formulae. Three chapters address quality-of-life topics. In addition to the core material, the book also includes chapters on some ancillary topics like patents and package inserts."
[My comment on the above writing is that the chapter on STATISTICS contains seventeen (17) mathematical formulas.]
The published review by Dr. Goldfarb also states, "Essential reading for clinical research professionals."
The published review also reveals this:
"The section on study designs discusses and provides diagrams for 17 schemas. The following text illustrates the book's fairly technical style:
FORWARDS SEQUENCE AND REVERSE SEQUENCE -- THE PUHALLA SCHEMA.
The clinical trial of Puhalla et al. (38) contains two arms (Fig. 2.8). Subjects in the first arm received drugs in this order: D followed by AC. In detail, subjects received docetaxel on the first day of each cycle, for 4 cycles, where each cycle was 14 days long. This was followed by doxorubicin (an anthracycline drug) plus cyclophosphamide, on the first day of each cycle, for 4 cycles. Each cycle was 2 weeks long.
Now, this is about the second arm. Subjects in the second arm received drugs in the reverse order, that is, AC followed by D.
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