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A shortened study design for embryo-fetal development studies in the minipig

机译：MINIPIG胚胎胎儿开发研究的缩短研究设计

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The minipig is accepted from scientific and regulatory perspectives for the safety evaluation of drug candidates on embryo-fetal development. The relative size and the duration of gestation (112–115 days) in the minipig is, however, considered a drawback compared with routine smaller species. We evaluated if study duration and cost could be optimized without impacting scientific validity by performing all terminal procedures around mid-gestation (60 days). At this stage, minipig fetal size is not too dissimilar to full term rabbit and therefore better suited to fetal processing/examination compared with at the end of gestation. Despite encountering higher than anticipated embryo-fetal death, morphological defects clearly associated with a known teratogen, pyrimethamine, were detected. Although the gonads are poorly differentiated macroscopically at mid-term, a histological examination confirmed that external sexing of the fetuses was accurate. Double staining of the bone and cartilage of the mid-term fetal skeleton allowed a more refined examination.
机译：MINIPIG从科学和监管的角度接受，为胚胎胎儿发育的药物候选者的安全评估。然而，与常规较小物种相比，MINIPIG中妊娠（112-115天）的相对尺寸和持续时间（112-115天）被认为是缺点。如果通过在中间妊娠周围的所有终端程序（60天），可以优化研究持续时间和成本，可以优化研究持续时间和成本。在这个阶段，Minipig胎尺寸与全术语兔子过于异常，因此与妊娠结束时，更适合胎儿加工/检查。尽管遇到高于预期的胚胎死亡，但检测到与已知的致致辛嘧啶，嘧霉素明显相关的形态缺陷。虽然Gonads在中期宏观分化不足，但组织学检查证实，胎儿的外部性别是准确的。双重胎儿骨骼的骨和软骨的双染色允许更精细的检查。

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