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Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

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Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines - Gad, Shayne C
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The inspiration for this text was the 1988 volume by Alder and Zbinden. Since then, much has changed. But 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.

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Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines 2014, Springer, New York, NY

ISBN-13: 9781489981875

2011 edition

Trade paperback

Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines 2010, Springer, New York, NY

ISBN-13: 9781441974488

Hardcover