Baldrick Paul
Nonclinical Regulatory Strategy, Covance Laboratories Ltd., Otley Road, Harrogate, HG3 1PY North Yorkshire, United Kingdom.
Regul Toxicol Pharmacol. 2013 Nov;67(2):125-35. doi: 10.1016/j.yrtph.2013.07.009. Epub 2013 Jul 26.
Recent formalised regulatory requirements for ensuring safe use of new drugs in children has increased the requirement, when considered relevant, to perform juvenile animal testing before commencing paediatric clinical trials. A key goal of this work is to identify or examine for a developmental or toxicity finding not seen in other toxicology testing. With our current knowledge, this paper examines what types of testing are occurring, what novel findings are being seen and their relevance in the safety evaluation process. Furthermore, trends for now and the future in the type of juvenile animal testing will be described including a need for more focused study designs and more published data on modern cross-species postnatal development.
近期为确保新药在儿童中安全使用而制定的正式监管要求，增加了在开展儿科临床试验之前（若认为有必要）进行幼年动物试验的要求。这项工作的一个关键目标是识别或检查在其他毒理学试验中未发现的发育或毒性结果。基于我们目前的认知，本文探讨了正在进行的试验类型、所观察到的新发现及其在安全性评估过程中的相关性。此外，还将描述当前及未来幼年动物试验类型的趋势，包括需要更具针对性的研究设计以及更多关于现代跨物种产后发育的已发表数据。
