Science/Engineering Development and Approval of Combination Products: A Regulatory Perspective By Evan B. Siegel (0470050942)

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Development and Approval of Combination Products: A Regulatory Perspective By Evan B. Siegel

The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are:

* The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products

* Approaches to clinical trial protocol design and execution

* Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products

* Key sponsor/FDA meetings and negotiations essential for approval and commercialization

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	Business/Investing Creating Breakthrough Products: Innovation from Product Planning to Program Approval Creating Breakthrough ProductsFT Press \| 2001-11-01 \| ISBN: 0139696946 \| 336 pages \| PDF \| 4,9 MBCagan and Vogel make a substantial contribution to the field of Industrial Design with "Creating Breakthrough Products." This book admirably st ...
	Science/Engineering Safety Evaluation in the Development of Medical Devices and Combination Products, 3 Ed Shayne C. Gad, Marian G. McCord, "Safety Evaluation in the Development of Medical Devices and Combination Products, 3 Ed" Informa HealthCare \| 2008-10-20 \| ISBN: 1420071645 \| 504 pages \| PDF \| 5,7 MB Capturing the growth of the global m ...
	Study Combination Products: Regulatory Challenges and Successful Product Development Smita Gopalaswamy, Venky Gopalaswamy "Combination Products: Regulatory Challenges and Successful Product Development"CRC \| 2008-04-22 \| ISBN: 1420064460 \| 264 pages \| PDF \| 1,7 MBThe field of combination product development (products born o ...
	Business/Investing Creating Breakthrough Products: Innovation from Product Planning to Program Approval (Repost) Jonathan Cagan, Craig M. Vogel - Creating Breakthrough Products: Innovation from Product Planning to Program ApprovalFT Press \| 2001 \| ISBN: 0139696946 \| Pages: 336 \| PDF \| 4.90 MBTransforms innovation from serendipity to science, giving yo ...
	Science/Engineering The Regulatory Genome: Gene Regulatory Networks In Development And Evolution Eric H. Davidson, "The Regulatory Genome: Gene Regulatory Networks In Development And Evolution"Academic Press \| 2006-05-30 \| ISBN: 0120885638 \| 304 pages \| PDF \| 5,7 MBGene regulatory networks are the most complex, extensive control sy ...
	Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition This Second Edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based appr ...

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