...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Birth defects research, Part B. Developmental and reproductive toxicology >Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors.
【24h】

Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors.

机译：用于儿科药物开发的青少年动物研究：欧洲药品管理局针对非临床评估人员进行的青少年动物测试研讨会的描述和结论。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

A workshop organised by the European Medicines Agency involved assessors and experts present in a Nonclinical Working Group evaluating juvenile animal studies for Paediatric Investigation Plans in collaboration with the Paediatric Committee and the Safety Working Party of the Committee for Human Medicinal Products. The objective of the workshop was to analyse which juvenile animal studies proposals were received and agreed by the Paediatric Committee, to check consistency and how to apply the existing European guideline on juvenile animal studies. A comparison of main organ system development in man vs. animal species was presented to guide the review and to support species selection and protocol design. An analysis of juvenile animal studies included in finalised PIP's was also presented. Out of 109 paediatric investigation plans finalised between November 2008 and March 2009, 43 included one or more juvenile animal studies. In most cases the preferred species was the rat; one species only was requested to be studied (20/22), but in a minority two species were required (2/22). When deciding on the characteristics of the juvenile animal studies, such as age of animals at study start, the age of the children targeted by the medicine was considered. It is expected that the increasing experience gained by Applicants and Regulators will allow further refining the criteria for these juvenile animal studies. Further research on this topic is highly encouraged in the European Regulatory framework.
机译：欧洲药品管理局组织的讲习班与非临床工作组的评估人员和专家一起，在非临床工作组中与儿科委员会和人类药物产品委员会的安全工作组合作，对儿科研究计划的青少年动物研究进行评估。讲习班的目的是分析儿科委员会收到并同意了哪些少年动物研究建议，以检查一致性，以及如何应用现有的欧洲少年动物研究指南。提出了人与动物物种主要器官系统发育的比较，以指导综述并支持物种选择和方案设计。还介绍了最终确定的PIP中包括的幼体动物研究分析。在2008年11月至2009年3月完成的109项儿科调查计划中，有43项包括一项或多项幼年动物研究。在大多数情况下，首选的物种是大鼠。只要求研究一种（20/22），而少数则需要两种（2/22）。在确定幼年动物研究的特征（例如研究开始时的动物年龄）时，应考虑使用该药物作为目标的儿童的年龄。可以预期的是，申请人和管理者所获得的越来越多的经验将使这些幼小动物研究的标准进一步完善。在欧洲法规框架中，强烈鼓励对此主题进行进一步研究。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号