关于缬沙坦产品中 NDMA（N-亚硝基二甲胺）污染的简短评论。
Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products.
机构信息
Xiphora Biopharma Consulting, Bristol, UK.
David P Elder Consultancy, Hertford, UK.
出版信息
Regul Toxicol Pharmacol. 2019 Apr;103:325-329. doi: 10.1016/j.yrtph.2019.01.007. Epub 2019 Jan 8.
PMID:30629969
Abstract
A range of generic valsartan products have been found to be contaminated with nitrosamines (principally N-nitrosodimethylamine; NDMA). We present information and discuss various elements of this phenomenon including: actions taken by regulatory agencies, source of the nitrosamine impurities, range of possible risk assessments based mainly on ICH M7 criteria, epidemiological assessment and analytical aspects.
摘要
已发现多种通用缬沙坦产品受到亚硝胺（主要是 N-亚硝基二甲胺；NDMA）污染。我们提供了有关这一现象的各种信息并进行了讨论，包括：监管机构采取的行动、亚硝胺杂质的来源、主要基于 ICH M7 标准的可能风险评估范围、流行病学评估和分析方面。
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