Safety Evaluation of Pharmaceuticals and Medical Devices is popular PDF and ePub book, written by Shayne C. Gad in 2010-10-26, it is a fantastic choice for those who relish reading online the Medical genre. Let's immerse ourselves in this engaging Medical book by exploring the summary and details provided below. Remember, Safety Evaluation of Pharmaceuticals and Medical Devices can be Read Online from any device for your convenience.
Safety Evaluation of Pharmaceuticals and Medical Devices Book PDF Summary
The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Detail Book of Safety Evaluation of Pharmaceuticals and Medical Devices PDF
- Author : Shayne C. Gad
- Release : 26 October 2010
- Publisher : Springer Science & Business Media
- ISBN : 9781441974495
- Genre : Medical
- Total Page : 135 pages
- Language : English
- PDF File Size : 20,5 Mb
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