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首页> 外文期刊>Reproductive toxicology >Nonclinical safety evaluation of anticancer medicines for pae-diatric population (PP): A role for juvenile animal studies?
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Nonclinical safety evaluation of anticancer medicines for pae-diatric population (PP): A role for juvenile animal studies?

机译：儿科人群抗癌药物的非临床安全性评估：在青少年动物研究中的作用？

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Introduction: When planning the paediatric development of any pharmaceutical, aspects that need to be taken into consideration include the understanding of a potential for modified sensitivity vs. adults, unique toxicities, or potential for effects on organ development. The usefulness of adult data for paediatric population depends on multiple factors including age and stage of development. The needs for early consideration of paediatric population (PP) have led to an increased focus on the relevance of nonclinical studies in juvenile animals (JAS).The immaturity of the developing organ may increase the potential for new target organs, modified activity or greater toxicity than has previously been seen in adults [1 ]. The underlying criteria for requesting JAS and design are stated in EU Committee for Medicinal Products for Human Use guideline [2 ]. While needing to screen for potential safety concerns associated to medicines use in children, avoiding useless studies and animal protection principles are strongly taken into consideration also. The need for animal studies for anticancer drugs is in general a matter of controversy in particular for the most severe forms.
机译：简介：在规划任何药物的儿科开发时，需要考虑的方面包括对与成人相比敏感性提高的潜力，独特的毒性或对器官发育的影响的潜力的理解。成人数据对儿科人群的有用性取决于多种因素，包括年龄和发育阶段。早期考虑儿科人群（PP）的需求已导致越来越多地关注幼年动物（JAS）的非临床研究的相关性。发育中器官的不成熟可能会增加新靶标器官，修饰活性或增强毒性的潜力。比以前在成人中看到的要多[1]。要求用于JAS和设计的基本标准在欧盟人用药用产品委员会指南[2]中进行了说明。尽管需要筛查与儿童服用药物有关的潜在安全问题，但也强烈考虑避免无用的研究和动物保护原则。对于抗癌药进行动物研究的需求通常存在争议，尤其是对于最严重的形式。

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