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Scientific and regulatory policy committee (SRPC) paper: Assessment of circulating hormones in nonclinical toxicity studies III. Female reproductive hormones

机译：科学与监管政策委员会（SRPC）论文：非临床毒性研究中循环激素的评估III。女性生殖激素

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摘要

Hormonally mediated effects on the female reproductive system may manifest as pathologic changes of endocrine-responsive organs and altered reproductive function. Identification of these effects requires proper assessment, which may include investigative studies to profile female reproductive hormones. Here, we briefly describe normal hormonal patterns across the estrous or menstrual cycle and provide general guidance on measuring female reproductive hormones and characterizing hormonal disturbances in nonclinical toxicity studies. Although species used in standard toxicity studies share basic features of reproductive endocrinology, there are important species differences that affect both study design and interpretation of results. Diagnosing female reproductive hormone disturbances can be complicated by many factors, including estrous/menstrual cyclicity, diurnal variation, and age- and stress-related factors. Thus, female reproductive hormonal measurements should not generally be included in first-tier toxicity studies of standard design with groups of unsynchronized intact female animals. Rather, appropriately designed and statistically powered investigative studies are recommended in order to properly identify ovarian and/or pituitary hormone changes and bridge these effects to mechanistic evaluations and safety assessments. This article is intended to provide general considerations and approaches for these types of targeted studies.
机译：对女性生殖系统的激素介导作用可能表现为内分泌反应器官的病理变化和生殖功能改变。对这些影响的鉴定需要适当的评估，其中可能包括调查研究以分析女性生殖激素。在这里，我们简要描述整个发情期或月经周期的正常荷尔蒙模式，并在非临床毒性研究中为测量女性生殖激素和表征荷尔蒙紊乱提供一般指导。尽管在标准毒性研究中使用的物种具有生殖内分泌学的基本特征，但是仍然存在重要的物种差异，这会影响研究设计和结果解释。女性生殖激素紊乱的诊断可能会因许多因素而复杂化，包括发情/月经周期，昼夜变化以及与年龄和压力相关的因素。因此，对雌性生殖激素的测量通常不应包括在标准设计的未同步雌性动物群的一级毒性研究中。相反，建议进行适当设计和以统计学为依据的调查研究，以正确识别卵巢和/或垂体激素的变化，并将这些影响与机械评估和安全性评估联系起来。本文旨在为这些类型的靶向研究提供一般性的考虑和方法。

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