By Evan B. Siegel
utilizing a confirmed built-in method of mix drug improvement, this booklet publications you step-by-step via the entire preclinical, scientific, and production levels. Written from an FDA regulatory point of view, the ebook not just helps you to convey a winning mix drug product to marketplace, it additionally units forth the best and powerful route to FDA approval.
The booklet starts off with an introductory bankruptcy offering definitions and simple regulatory rules of mix items. subsequent, it studies production and controls, preclinical trying out versions, pharmacology, scientific trying out, regulatory submissions, FDA studies, and approvals. one of the key subject matters tested are:
* The pharmacology, safeguard pharmacology, and toxicology assisting human scientific trials of blend products
* methods to medical trial protocol layout and execution
* Chemical, physicochemical, and analytical elements of producing controls and validation that bring about solid elements for mix products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization
Case stories related to such genuine mix items as Mylotarg, Herceptin, and HercepTest assist you larger know the way to enforce the author's functional instructions. References on the finish of every bankruptcy assist you locate additional information on any level of the advance, production and approval processes.
This publication is perfect for researchers, regulators, teachers, undertaking managers, and managers curious about the advanced means of mixture product improvement. not just does itoffer a accomplished advisor to the technical facets of the sphere, it additionally integrates all ofthese technical elements right into a unified, powerful method of support make certain a winning, authorized product.
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Development and Approval of Combination Products: A Regulatory Perspective by Evan B. Siegel