Colman, Karyn (2016) Impact of the Genetics and Source of Preclinical Safety Animal Models on Study Design, Results and Interpretation. Toxicologic pathology, ? (?). pp. 1-13. ISSN 1533-1601; 0192-6233

Abstract

It has been long established that not only the species but also the strain and supplier of rodents used in preclinical safety studies can have a significant impact on the outcome of studies due to variability in their genetic background and thus spontaneous pathologic findings. In addition, local husbandry, housing and other environmental conditions may have effects on the development and expression of co-morbidities, particularly in longer-term or chronic studies. More recently, similar effects related to the source, including genetic and environmental variability, have been recognized in Cynomolgus macaques (M. fascicularis). The increased use of cynos from various sources of captive-bred animals (including non-native, US/EU-based breeding facilities or colonies) can affect study design and study results and outcome. It is important to acknowledge and understand the impact of this variability on the results and interpretation of research studies. This review includes recent examples where variability of preclinical animal models (rats and cynos) affected the post-mortem observations and its relevance to study design or interpretation in safety studies.

Item Type:	Article
Keywords:	Rat, Cynomolgus monkey, genetic variability, environment, source, geographic origin
Date Deposited:	21 Oct 2016 00:45
Last Modified:	21 Oct 2016 00:45
URI:	https://oak.novartis.com/id/eprint/30238