By Evan B. Siegel
utilizing a confirmed built-in method of mix drug improvement, this publication publications you step-by-step via the entire preclinical, scientific, and production levels. Written from an FDA regulatory viewpoint, the publication not just permits you to convey a profitable mix drug product to industry, it additionally units forth the best and powerful route to FDA approval.
The booklet starts off with an introductory bankruptcy providing definitions and simple regulatory ideas of blend items. subsequent, it reports production and controls, preclinical trying out versions, pharmacology, scientific trying out, regulatory submissions, FDA studies, and approvals. one of the key issues tested are:
* The pharmacology, defense pharmacology, and toxicology assisting human medical trials of blend products
* techniques to scientific trial protocol layout and execution
* Chemical, physicochemical, and analytical facets of producing controls and validation that result in sturdy elements for mix products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization
Case experiences regarding such genuine blend items as Mylotarg, Herceptin, and HercepTest assist you higher know how to enforce the author's functional guidance. References on the finish of every bankruptcy provide help to locate additional information on any degree of the advance, production and approval processes.
This e-book is perfect for researchers, regulators, lecturers, undertaking managers, and bosses all in favour of the complicated technique of mix product improvement. not just does itoffer a entire consultant to the technical elements of the sphere, it additionally integrates all ofthese technical elements right into a unified, potent method of aid determine a profitable, authorized product.
Read or Download Development and Approval of Combination Products: A Regulatory Perspective PDF
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A step by step, built-in technique for profitable, FDA-approved mixture drug items utilizing a confirmed built-in method of mix drug improvement, this booklet courses you step-by-step via the entire preclinical, medical, and production levels. Written from an FDA regulatory standpoint, the e-book not just allows you to carry a profitable mixture drug product to industry, it additionally units forth the most productive and potent route to FDA approval.
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Development and Approval of Combination Products: A Regulatory Perspective by Evan B. Siegel