Preclinical development handbook - Toxicology Печать
Preclinical-Development-Handbook-Toxicology2008 This Preclinical Development Handbook: Toxicology focuses on the methods ofidentifying and understanding the risks that are associated with new potential drugsfor both large and small therapeutic molecules. This book continues the objectivebehind this entire Handbook series: an attempt to achieve a through overview ofthe current and leading - edge nonclinical approaches to evaluating the nonclinicalsafety of potential new therapeutic entities. Thanks to the persistent efforts of MindyMyers and Gladys Mok, the 31 chapters cover the full range of approaches to identifyingthe potential toxicity issues associated with the seemingly unlimited rangeof new molecules. These evaluations are presented with a thorough discussion ofhow the approaches fi t into the mandated regulatory requirements for safety evaluationas mandated by the U.S. Food and Drug Administration and other regulatoryauthorities. They range from studies on potential genotoxicity and cardiotoxicity incultured cells to a two - year study in rats and mice to identify potentially tumorigenicproperties.The volume differs from the others in this series in that although the methodsused by the researchers are fi xed by regulation at any one time, these methods areincreasingly undergoing change as it is sought to become ever more effective atidentifying potential safety issues before they appear in patient populations.Although we will never achieve perfection in this area, we continue to investigatenew ways of trying to do so.

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