Bogdanffy, Matthew S, Lesniak, Jacob, Mangipudy, Raja, Stanley, Ann Marie, Colman, Karyn and Blanset, Diann (2020) Tg.rasH2 mouse model for Assessing Carcinogenic Potential of Pharmaceuticals: Industry Survey and Recommendations. International Journal of Toxicology. ISSN 1091-58181092-874X

Abstract

The Tg.rasH2 mouse was developed as a model for the alternative carcinogenicity testing. As an alternative to traditional 2-year mouse bioassay, this model has found extensive use in support of biopharmaceutical drug development over the last few decades. It has the potential of improving quality, timeliness, reduction of animal numbers, and in some instances allow expedient decision making regarding the potential for human carcinogenicity. Despite the increased use of the Tg.rasH2 model, there has been no systematic survey of current practices in the design, interpretation of results from the bioassay, and global health authority perspectives. Therefore, the aim of this work was to poll the pharmaceutical industry on study design practices used in the dose range finding and definitive 6-month Tg.rasH2 study, and on results relative to the ongoing revisions to ICH S1. Participants in the survey are member companies of IQ DruSafe. The survey results provide very useful insights in study design and interpretation. Importantly, the results identified several key opportunities for reducing animal use and increasing the value of testing for potential human carcinogenicity using this model.

Item Type:	Article
Keywords:	Tg.rasH2, Pharmaceuticals, Carcinogenicity, IQ DruSafe
Date Deposited:	20 May 2020 00:45
Last Modified:	20 May 2020 00:45
URI:	https://oak.novartis.com/id/eprint/41666