By Evan B. Siegel
utilizing a confirmed built-in method of mixture drug improvement, this booklet publications you step-by-step via all of the preclinical, scientific, and production phases. Written from an FDA regulatory point of view, the ebook not just permits you to deliver a profitable blend drug product to marketplace, it additionally units forth the most productive and powerful route to FDA approval.
The ebook starts with an introductory bankruptcy proposing definitions and uncomplicated regulatory rules of mixture items. subsequent, it reports production and controls, preclinical trying out versions, pharmacology, scientific trying out, regulatory submissions, FDA experiences, and approvals. one of the key themes tested are:
* The pharmacology, defense pharmacology, and toxicology helping human scientific trials of mixture products
* ways to scientific trial protocol layout and execution
* Chemical, physicochemical, and analytical features of producing controls and validation that result in strong parts for blend products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization
Case reports regarding such real blend items as Mylotarg, Herceptin, and HercepTest assist you larger know the way to enforce the author's useful instructions. References on the finish of every bankruptcy show you how to locate additional information on any degree of the improvement, production and approval processes.
This booklet is perfect for researchers, regulators, teachers, undertaking managers, and bosses interested by the complicated means of blend product improvement. not just does itoffer a entire advisor to the technical points of the sphere, it additionally integrates all ofthese technical points right into a unified, powerful method of support verify a winning, authorized product.
Read or Download Development and Approval of Combination Products: A Regulatory Perspective PDF
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Extra info for Development and Approval of Combination Products: A Regulatory Perspective
Development and Approval of Combination Products: A Regulatory Perspective by Evan B. Siegel