Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

by Shayne C. Gad

Book Overview

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...

• Format: Hardcover
• Language: English
• ISBN: 1441974482
• ISBN13: 9781441974488
• Release Date: October 2010
• Publisher: Springer
• Length: 126 Pages
• Weight: 0.59 lbs.
• Dimensions: 0.5" x 6.4" x 9.5"