Strategies for conducting juvenile dose ranging studies before definitive toxicity juvenile animal studies (JAS) have evolved, but the aim of demonstrating study design robustness and efficient animal use remains the same. The objective of dose selection is to identify a strategy to achieve consistent systemic exposure for the duration of the JAS while maintaining exposure separation between dose groups. For preweaning rodents this can prove challenging, as these studies typically treat animals over a broad period of considerable organ development.

中文翻译：

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啮齿动物断奶前幼年动物研究的剂量范围寻找方法

在确定毒性幼年动物研究 (JAS) 之前进行幼年剂量范围研究的策略已经发展，但证明研究设计稳健性和有效动物使用的目标仍然相同。剂量选择的目的是确定一种策略，以在 JAS 期间实现一致的全身暴露，同时保持剂量组之间的暴露分离。对于断奶前的啮齿动物来说，这可能具有挑战性，因为这些研究通常在相当长的器官发育过程中对动物进行治疗。