| Literature DB >> 30629969 |
David J Snodin1, David P Elder2.
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.Entities:
Keywords: Mutagenic carcinogen; N-nitrosodimethylamine (NDMA); Risk assessment; Valsartan
Mesh：
Substances：
Year: 2019 PMID： 30629969 DOI： 10.1016/j.yrtph.2019.01.007
Source DB: PubMed Journal: Regul Toxicol Pharmacol ISSN： 0273-2300 Impact factor: 3.271