Use of juvenile animal studies to support oncology medicine development in children
Use of juvenile animal studies to support oncology medicine development in children
复制标题
DOI：
10.1016/j.reprotox.2015.05.005
复制
发表时间：
2015-08-15
影响因子：
3.3
通讯作者：
Duarte, Dinah M.
中科院分区：
文献类型：
--
作者：
Duarte, Dinah M.
由于对儿童的长期影响，儿童癌症仍然是一个挑战。需要扩大儿童获得新的癌症治疗，需要早期预测具体的安全性方面，正在进行幼年动物研究（JAS），以筛选与年龄有关的毒性和出生后发育期间发生的差异。本文调查了欧盟（1995-2014年）和PIP（儿科研究计划-2007-2014年）批准的肿瘤学药物，通过评估药物标签信息，了解JAS在其非临床开发中的有用性。药物和PIP的回顾性审查显示，JAS的稳定使用可以更好地表征安全性：大约三分之一的肿瘤药物或PIP进行了JAS。对于6种含JAS的抗癌药物，成年和幼龄动物的毒性特征在研究结果中显示出一些差异。这些病例的讨论说明了JAS在肿瘤药物中的潜在意义。(C)2015 Elsevier Inc. All rights reserved.
Childhood cancer has remained a challenge because of long-term effects in children. The need to extend access of children into new cancer therapies requires early prediction of specific safety aspects and juvenile animal studies (JAS) are being conducted to screen for age-related toxicities and differences occurring during postnatal development. This paper investigates oncology approved medicines in the EU (1995-2014) and PIP (Paediatric Investigation Plans - 2007-2014), regarding the usefulness of JAS in their non-clinical development by evaluating information on the medicines labelling. The retrospective review from medicines and PIPs revealed a steady use of JAS to better characterize safety: Approximately 1 in 3 oncology medicine or PIP has conducted JAS. For 6 of the cancer medicines with JAS the toxicity profile in adult and juvenile animals showed some differences in study findings. The discussion of these cases is illustrative of the potential significance that JAS have provided in oncology medicines. (C) 2015 Elsevier Inc. All rights reserved.