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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology

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Safety Evaluation of Pharmaceuticals and Medical Devices - International Regulatory Guidelines (Paperback, 2011 ed.) Loot Price: R4,183
Discovery Miles 41 830
Repayment Terms: R392 pm x 12*
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Safety Evaluation of Pharmaceuticals and Medical Devices - International Regulatory Guidelines (Paperback, 2011 ed.): Shayne C...

Safety Evaluation of Pharmaceuticals and Medical Devices - International Regulatory Guidelines (Paperback, 2011 ed.)

Shayne C Gad

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Loot Price R4,183 Discovery Miles 41 830 | Repayment Terms: R392 pm x 12*

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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.

General

Imprint: Springer-Verlag New York
Country of origin: United States
Release date: October 2014
First published: 2011
Authors: Shayne C Gad
Dimensions: 235 x 155 x 8mm (L x W x T)
Format: Paperback
Pages: 126
Edition: 2011 ed.
ISBN-13: 978-1-4899-8187-5
Categories: Books > Medicine > Nursing & ancillary services > Pharmacy / dispensing
Books > Medicine > Other branches of medicine > Pharmacology > General
Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN: 1-4899-8187-X
Barcode: 9781489981875

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