Charlotte E Laupheimer, Yana Kolianchuk, Rex E FitzGerald, Martin F Wilks, Arne Jaksch
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引用次数: 0
Abstract
Vanadium is used in alloys, batteries as well as catalyst and is a known impurity in medical devices and pharmaceuticals. The present work describes the calculation of a parenteral tolerable intake (TI) for vanadium by chronic exposure in implantable medical devices per ISO 10993-17:2023, the applicable standard. The 2023 update of ISO 10993-17 [1] introduces new uncertainty factors (UFs) for calculating a TI. Therefore, we noted differences between the ISO guidance and the ICH Q3D guidance on Permissible Daily Exposure (PDE) for parental elemental pharmaceutical impurities. We derived a TI of 0.20 μg V/kg/day based on the updated ISO guidance, and a PDE of 0.24 μg V/kg/day based on ICH guidance. The latter is considered a more realistic estimate.
钒用于合金、电池和催化剂，也是医疗器械和药品中的一种已知杂质。本研究介绍了根据 ISO 10993-17:2023（适用标准）计算植入式医疗器械中长期接触钒的肠外耐受摄入量（TI）。ISO 10993-17[1]的2023更新版引入了计算TI的新不确定系数（UF）。因此，我们注意到 ISO 指南与 ICH Q3D 指南中关于亲元素药物杂质每日允许暴露量 (PDE) 的不同之处。根据最新的 ISO 指南，我们得出 TI 为 0.20 μg V/kg/day，而根据 ICH 指南，PDE 为 0.24 μg V/kg/day。后者被认为是更切合实际的估计值。
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Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health.
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