Quantitative Evaluation of Safety in Drug Development _ Design, Analysis and Reporting (2014)

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Drug safety has always been important, but it has undergone increased scrutiny in recent years. This book is about quantitative evaluation of the safety of biopharmaceutical products. The book is meant to be comprehensive, covering design, monitoring, analysis, and reporting issues for both clinical trials and observational studies. In addition, since statistical methods for drug safety assessment are still evolving and new methods are under development, the book will cover developments in state-of-the-art methods for drug safety assessment. We hope our book will bring the most advanced knowledge and statistical methodology to the statistical, clinical, and safety community; share best practices; and stimulate further research and methodology development in the drug safety area.

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