Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 66, Issue 1, Pages 88-103Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2013.03.001
Keywords
Safety; Toxicology; 3Rs; In vitro methods; Safety pharmacology; Rodents; Biologicals; New chemical entities; Developmental; Reproductive
Categories
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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Evaluation of the safety of new chemicals and pharmaceuticals requires the combination of information from various sources (e.g. in vitro, in silico and in vivo) to provide an assessment of risk to human health and the environment. The authors have identified opportunities to maximize the predictivity of this information to humans while reducing animal use in four key areas; (i) accelerating the uptake of in vitro methods; (ii) incorporating the latest science into safety pharmacology assessments; (iii) optimizing rodent study design in biological development and (iv) consolidating approaches in developmental and reproductive toxicology. Through providing a forum for open discussion of novel proposals, reviewing current research and obtaining expert opinion in each of the four areas, the authors have developed recommendations on good practice and future strategy. (C) 2013 Elsevier Inc. All rights reserved.
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