Clinical Trials. Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines Cover

Clinical Trials. Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

ISBN/ASIN: 9780123919113 | 2011 | English | pdf | 637/637 pages | 6.94 Mb
Publisher: Academic Press | Author: Tom Brody (Auth.)

''…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. Because the book is not about trial conduct, it does not focus on topics like regulatory compliance, human subjects protection, or case report forms.''–Journal of Clinical Research Best Practices, September 2012, Vol. 8, No. 9

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