Endocrine Disruptors

作物保护

内分泌破坏剂(Ed)是一种干扰身体内分泌系统产生不良反应的物质。这些不利影响可能影响发育,繁殖,神经功能或免疫系统 - 影响个体动物,人群和生态系统。全球监管机构越来越需要评估指示物质引起内分泌破坏的潜力的终点。

Covance ED测试的最前沿,leading the field in the adoption and validation of ED testing approaches relevant to regulatory authorities in Europe, the US and around the world. By building capabilities and capacity that stay ahead of the scientific and regulatory curve, your current and future needs are catered for. Partner with us and let us help navigate you through the scientific, technical and regulatory complexity of ED testing.

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  • 一项战略科学方法与监管洞察力相结合,优化了ED测试,并允许美国从强大的证据基础上建立引人注目的监管论点
  • 体外广泛和体内测试能力提供了适用于世界各地的监管机构的强大和可信数据,包括EPA,EFSA和ECHA
  • 尖端技术回答了与甲状腺激素分析相关的最具挑战性问题

您的需求:

Endocrine disruptor (ED) programs can be technically challenging to plan, run and interpret

ED筛选测试可能是挑战,以便进行和解释。监管终点因监管机构而异,不断发展。为了优化您的测试程序的价值和效率,您需要高水平的技术专业知识和优异的科学洞察力。知情的学习设计最大限度地提高了数据的价值并降低了ED测试程序中的冗余。但是,找到适当的专业知识和能力可能是一个挑战。

可以难以制作赢得监管机构的连贯争论

目录是目录,您需要以与监管机构相关的方式来解释您的硅,体外和体内ed数据。

可靠的分析,特别是对于甲状腺激素测量,并不广泛可用

A major challenge in ED testing is the accurate measurement of thyroid hormones levels at very low concentrations. Many ED assays require the measurement of serum thyroid hormones T3 and T4 in fetuses or pups. In such young animals, thyroid hormone levels may be in the low pg/mL level. This is at the detection limits of standard analytical approaches, which undermines the reliability of your test results. You need a partner who has this capability to measure such low levels.

与内分泌干扰终点相关的历史控制数据

要有效地解释ED测试的结果,您需要将它们与控制数据进行比较。最佳比较器是多年来收集的历史数据。对于一些新的终点,如甲状腺激素水平,这种历史数据可能无法使用或可能是不可靠的。


我们的能力

Designing the optimum ED testing strategy matched to your needs

Covance can partner with you in a flexible way to help clarify and address your needs. With ED testing insight gained from multiple EU and US submissions, our experts can leverage their knowledge to support you. Whether you need scientific guidance on an ED testing strategy or simply a set of ED tests run to high standards, we can help. Click the link below to explore our ED testing capabilities and how they can be utilized for all global regulators:

通过与内分泌干扰者相关的复杂监管雷区支持您

Leverage the experience and insights of regulatory experts, scientists, analytical chemists and data modellers to build weight of evidence arguments supporting your substance’s ED profile. By taking an integrated approach, Covance can make scientific arguments that stand up to regulatory scrutiny. Find out more about the comprehensive support on offer here:

甲状腺激素测量中的尖端技术

Covance开创了一个内部方法,敏感,准确地评估甲状腺激素T3和T4降至低pg / ml浓度。该技术涉及使用UHPLC-MS / MS,并且已广泛应用于需要甲状腺功能评估的一系列经合组织和EPA研究。这通过提供可靠且可核性的甲状腺激素结果,这将克服了ED筛选的常见障碍。Covance可以为合作伙伴提供这种创新和行业领先的技术。

可靠的历史数据控制支持您的结果验证

景气开始在20世纪90年代的内分泌干扰测试中工作。这使我们能够建立可以从中受益的专业知识,洞察力,技术和历史数据集。我们的历史数据集对甲状腺激素测定尤为重要,并反映了我们在ED测试领域的创新。