Value in global standardization of outbred rats for regulatory pharmaceuticals studies.
As a result of a revolution in globalization over the last 10 years, few pharmaceutical companies conduct their non-clinical studies within a single region and virtually none conduct all non-clinical studies in house. The increased activity of product in-licensing at all stages of development results in further segmentation of toxicological source information. Juxtaposed to this segmental collection of toxicology information is the nature of toxicological testing for pharmaceuticals, an iterative process, carefully building subsequent testing designs and analyses upon the foundation of previously identified outcomes and associated safety issues. As a consequence of the segmentation of global product development, today's analyses of toxicological outcomes for single pharmaceutical projects often involve a conglomeration of results from studies conducted in several world regions using a variety of sources of animals. Such practices can lead to discordant study results and difficulty in understanding or rationalizing a compound's toxicological and pharmacological profile, and eventually how this relates to human risk. Despite the variety in source information, an integration of the total toxicology/pharmacology data must be made by industry, and/or by health authorities. To improve this integration, the development and use of better standardized genetics for rodent species used in pharmaceutical testing is more imperative today than in the past, as a result of a constellation of changes in industry policies.
van Cauteren
Herman
H
Novartis Pharma AG, Preclinical Safety, Basel, Switzerland.
Kammüller
Michael
M
DeGeorge
Joseph
J
D000818:Animals; D010600:Pharmacology; D051381:Rats / Q000235:genetics / Q000502:physiology*; D014116:Toxicology