Safety Evaluation of Pharmaceuticals and Medical Devices

International Regulatory Guidelines

Nonfiction, Health & Well Being, Medical, Specialties, Pharmacy, Medical Science, Pharmacology
Cover of the book Safety Evaluation of Pharmaceuticals and Medical Devices by Shayne C. Gad, Springer US
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Author: Shayne C. Gad ISBN: 9781441974495
Publisher: Springer US Publication: October 26, 2010
Imprint: Springer Language: English
Author: Shayne C. Gad
ISBN: 9781441974495
Publisher: Springer US
Publication: October 26, 2010
Imprint: Springer
Language: English

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.

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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.

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