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Regulatory risk assessments: Is there a need to reduce uncertainty and enhance robustness?

机译:监管风险评估:是否需要减少不确定性并增强稳健性?

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摘要

A critical evaluation of several recent regulatory risk assessments has been undertaken. These relate to propyl paraben (as a food additive, cosmetic ingredient or pharmaceutical excipient), cobalt (in terms of a safety-based limit for pharmaceuticals) and the cancer Threshold of Toxicological Concern as applied to food contaminants and pharmaceutical impurities. In all cases, a number of concerns can be raised regarding the reliability of the current assessments, some examples being absence of data audits, use of single-dose and/or non-good laboratory practice studies to determine safety metrics, use of a biased data set and questionable methodology and lack of consistency with precedents and regulatory guidance. Drawing on these findings, a set of recommendations is provided to reduce uncertainty and improve the quality and robustness of future regulatory risk assessments.
机译:已对近期的几项监管风险评估进行了严格评估。它们涉及对羟基苯甲酸丙酯(作为食品添加剂,化妆品成分或药物赋形剂),钴(就药品的基于安全性的限制而言)以及应用于食品污染物和药物杂质的毒理学关注的癌症阈值。在所有情况下,都会对当前评估的可靠性提出许多关注,例如缺少数据审核,使用单剂量和/或不良实验室实践研究来确定安全指标,使用偏见数据集和可疑方法,缺乏与先例和监管指南的一致性。根据这些发现,提供了一组建议,以减少不确定性并提高未来监管风险评估的质量和稳健性。

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