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Safety Evaluation of Pharmaceuticals and Medical Devices - International Regulatory Guidelines (Hardcover, 2011 Ed.)
Loot Price: R4,425
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Safety Evaluation of Pharmaceuticals and Medical Devices - International Regulatory Guidelines (Hardcover, 2011 Ed.)
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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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