Interface between Regulation and Statistics in Drug Development (2020) Pdf Free Download

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This book is aimed at researchers in the pharmaceutical industry and in academia with interest in drug development and, hence, in the design, conduct, analysis, and reporting of clinical trials or observational studies intended for regulatory purposes. As the title suggests, the primary focus of the book is on the intersection of statistics and regulatory affairs in the context of drug development. While the monograph is intended to be of primary interest to medical researchers and regulatory personnel, it may also serve as a useful reference for graduate students in the health sciences who wish to get an understanding of the statistical and regulatory issues that commonly arise in the course of drug development. The material is mostly written at a level that is accessible to readers with an intermediate knowledge of statistics.

The book consists of stand-alone chapters and sections, with each section dedicated to a specific topic in regulatory affairs and statistics. In each case, the authors have made a conscious effort to provide a survey of the relevant literature and to highlight emerging and current trends and guidelines for best practices, when the latter were available.

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