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药物毒理学:设计研究以减少动物使用,同时最大限度地提高人类转化。

Pharmaceutical toxicology: designing studies to reduce animal use, while maximizing human translation.

机构信息

UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UK.

出版信息

Regul Toxicol Pharmacol. 2013 Jun;66(1):88-103. doi: 10.1016/j.yrtph.2013.03.001. Epub 2013 Mar 21.

DOI:10.1016/j.yrtph.2013.03.001
PMID:23524271
Abstract

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.

摘要

评估新化学物质和药物的安全性需要结合来自各种来源的信息(例如体外、计算和体内),以评估对人类健康和环境的风险。作者已经确定了在四个关键领域中最大限度地提高信息对人类的预测性,同时减少动物使用的机会;(i)加速采用体外方法;(ii)将最新科学纳入安全药理学评估;(iii)优化生物开发中的啮齿动物研究设计和(iv)整合发育和生殖毒理学方法。通过提供一个开放讨论新提案的论坛,审查每个领域的当前研究和获取专家意见,作者就良好实践和未来战略提出了建议。

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