Medical Product Safety Evaluation_ Biological Models and Statistical Methods (2018) Pdf Free Download

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The past decade witnessed a greatly increased focus on safety evaluation of medical products in the pharmaceutical and biotechnology industries. Safety data are routinely collected throughout preclinical in-vitro and in-vivo experiments (e.g., living cells and animal models), clinical development (e.g., randomized clinical trials), and post-licensure studies and monitoring. Whereas most clinical trials are designed to investigate the hypothesized efficacy of a compound, safety outcomes are usually not defined a priori, making the problem of quick detection of safety signals subject to prescribed upper bounds on the rates of false signals and false non-signals particularly challenging. Our book aims at addressing these challenges and presenting cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety signal detection and benefit-risk assessment. Some frequently encountered issues and challenges in safety data analysis are discussed with illustrative applications and examples.

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