Shayne C Gad: 3 books
Contract Research and Development Organizations
Their Role in Global Product Development
Language: English
Release Date: August 4, 2011
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been...
by Shayne C. Gad, Christopher P. Chengelis
Language: English
Release Date: October 27, 1997
Language: English
Release Date: October 27, 1997
Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test...
Safety Evaluation of Pharmaceuticals and Medical Devices
International Regulatory Guidelines
Language: English
Release Date: October 26, 2010
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...