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
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Springer US

Cover of the book Models, Methods, Concepts & Applications of the Analytic Hierarchy Process by Shayne C. Gad
Cover of the book Food Biochemistry by Shayne C. Gad
Cover of the book Psychopathology of Human Adaptation by Shayne C. Gad
Cover of the book Patient Flow by Shayne C. Gad
Cover of the book Authigenic Minerals in Sedimentary Rocks by Shayne C. Gad
Cover of the book The Management of CAD for Construction by Shayne C. Gad
Cover of the book Psychiatric Consequences of Brain Disease in the Elderly: A Focus on Management by Shayne C. Gad
Cover of the book Environment and Culture by Shayne C. Gad
Cover of the book Pathophysiology of Pain Perception by Shayne C. Gad
Cover of the book Organizational Learning by Shayne C. Gad
Cover of the book Coping with HIV Infection by Shayne C. Gad
Cover of the book The Problem of Excitability by Shayne C. Gad
Cover of the book Laterite by Shayne C. Gad
Cover of the book Product Design for Modularity by Shayne C. Gad
Cover of the book Evoked Brain Potentials in Psychiatry by Shayne C. Gad
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy