By Evan B. Siegel
utilizing a confirmed built-in method of blend drug improvement, this publication courses you step-by-step via the entire preclinical, scientific, and production phases. Written from an FDA regulatory point of view, the ebook not just helps you to carry a winning mix drug product to marketplace, it additionally units forth the most productive and powerful route to FDA approval.
The ebook starts off with an introductory bankruptcy offering definitions and simple regulatory rules of blend items. subsequent, it studies production and controls, preclinical checking out types, pharmacology, scientific checking out, regulatory submissions, FDA stories, and approvals. one of the key themes tested are:
* The pharmacology, defense pharmacology, and toxicology helping human scientific trials of mixture products
* ways to medical trial protocol layout and execution
* Chemical, physicochemical, and analytical elements of producing controls and validation that result in reliable parts for mixture products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization
Case reviews regarding such genuine mixture items as Mylotarg, Herceptin, and HercepTest assist you larger know how to enforce the author's useful directions. References on the finish of every bankruptcy help you locate additional information on any level of the improvement, production and approval processes.
This ebook is perfect for researchers, regulators, teachers, venture managers, and bosses fascinated about the complicated technique of blend product improvement. not just does itoffer a complete advisor to the technical points of the sphere, it additionally integrates all ofthese technical features right into a unified, powerful method of support be certain a winning, authorized product.
Read Online or Download Development and Approval of Combination Products: A Regulatory Perspective PDF
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