Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 61, Issue 2, Pages 222-229Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2011.08.001
Keywords
Animal numbers; Toxicokinetics; Regulatory toxicology; Pharmaceuticals; Study design; Group size
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Funding
- AstraZeneca plc
- Covance Laboratories Ltd.
- GlaxoSmithKline plc
- Huntingdon Life Sciences Ltd.
- Eli-Lilly and Company Ltd.
- Pfizer Ltd.
- Novartis Pharmaceuticals Ltd.
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Toxicity studies in animals are carried out to identify the intrinsic hazard of a substance to support risk assessment for humans. In order to identify opportunities to minimise animal use in regulatory toxicology studies, a review of current study designs was carried out. Pharmaceutical companies and contract research organisations in the UK shared data and experience of standard toxicology studies (ranging from one to nine months duration) in rodents and non-rodents; and carcinogenicity studies in the rat and mouse. The data show that variation in study designs was primarily due to (i) the number of animals used in the main study groups, (ii) the use of animals in toxicokinetic (TK) satellite groups, and (iii) the use of animals in off-treatment recovery groups. The information has been used to propose a series of experimental designs where small adjustments could reduce animal use in practice, while maintaining the scientific objectives. (C) 2011 Published by Elsevier Inc.
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