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Not reinventing the wheel – applying 3Rs concepts to viral vector gene therapy biodistribution studies

Maclachlan, Timothy and McIntyre, Maritza and Jolly, Douglas and Mitrophanous, Kyriacos and Miskin, James and Holder, Julie and Cavagnaro, Joy (2013) Not reinventing the wheel – applying 3Rs concepts to viral vector gene therapy biodistribution studies. Human Gene Therapy Clinical Development, 24 (1). pp. 1-4.

Abstract

In pharmaceutical drug development, information on where a drug distributes within the body is helpful in understanding the overall chemical and/or biological characteristics of the compound. This is typically assessed preclinically in relevant animal species that are often used for the formal safety studies (toxicology, pharmacokinetics and drug metabolism. One accepted principle of animal studies is the application of the “3 R’s concept” (replacement, refinement and reduction http://www.nc3rs.org.uk/) to reduce animal use as far as makes sense. The focus of this article is to suggest that, for gene therapy biodistribution studies, reductions in animal use could be rationally achieved with no increase in clinical risk.

Item Type: Article
Date Deposited: 13 Oct 2015 13:13
Last Modified: 13 Oct 2015 13:13
URI: https://oak.novartis.com/id/eprint/9301

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