Development and Approval of Combination Products: A Regulatory Perspective By Evan B. Siegel

Description

The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are:
* The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products
* Approaches to clinical trial protocol design and execution
* Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products
* Key sponsor/FDA meetings and negotiations essential for approval and commercialization

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