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Clinical trials [recurso electrónico] : Study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines by Tom Brody PhD University of California at Berkeley is a nonfiction available to read on EtoBox.
What is Clinical trials [recurso electrónico] : Study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines about?
__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. * Provides extensive coverage of the "study schema" and related features of study design * Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design * Features examples from the medical literature to highlight how investigators
Who reads Clinical trials [recurso electrónico] : Study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines?
It is typically read by self-directed learners exploring a subject in depth.
Common subject areas: history, science, philosophy, social sciences.
- Author
- Tom Brody PhD University of California at Berkeley
- Publisher
- Elsevier/AP; Academic Press
- Published
- 2012
- Language
- EN
- ISBN
- 9780123919113
- Category
- nonfiction
- Subjects
- Medical, Medicine
- Rating
- 5 / 5 (6 ratings)
- Updated
- 2026-03-14
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