By Evan B. Siegel
A step by step, built-in process for profitable, FDA-approved mixture drug products
utilizing a confirmed built-in method of mixture drug improvement, this e-book publications you step-by-step via all of the preclinical, medical, and production phases. Written from an FDA regulatory point of view, the e-book not just allows you to deliver a profitable mix drug product to marketplace, it additionally units forth the best and powerful route to FDA approval.
The ebook starts off with an introductory bankruptcy proposing definitions and simple regulatory ideas of mixture items. subsequent, it studies production and controls, preclinical checking out versions, pharmacology, medical checking out, regulatory submissions, FDA studies, and approvals. one of the key issues tested are:
* The pharmacology, protection pharmacology, and toxicology aiding human medical trials of mixture products
* methods to medical trial protocol layout and execution
* Chemical, physicochemical, and analytical facets of producing controls and validation that bring about solid elements for blend products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization
Case reviews related to such real blend items as Mylotarg, Herceptin, and HercepTest assist you higher know the way to enforce the author's functional instructions. References on the finish of every bankruptcy provide help to locate additional information on any level of the advance, production and approval processes.
This e-book is perfect for researchers, regulators, teachers, undertaking managers, and managers concerned with the advanced means of mixture product improvement. not just does itoffer a complete advisor to the technical facets of the sphere, it additionally integrates all ofthese technical facets right into a unified, powerful method of aid confirm a winning, authorized product.Content:
Chapter 1 evaluation of mixture items improvement and Regulatory evaluate (pages 1–4): Evan B. Siegel
Chapter 2 specific Regulatory techniques to improvement, overview, and Approval (pages 5–75): James Barquest
Chapter three Nonclinical thoughts for profitable Characterization and improvement of mix Drug items (pages 77–111): Duane B. Lakings
Chapter four medical Pharmacology and medical improvement of mixture items (pages 113–170): Chaline Brown
Chapter five Regulatory method concerns for Chemistry, production, and Controls: An built-in procedure (pages 171–200): Patrick L. DeVillier