Short Commentary On Ndma (N-Nitrosodimethylamine) Contamination Of Valsartan Products Response
REGULATORY TOXICOLOGY AND PHARMACOLOGY(2019)
摘要
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.
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关键词
Skin sensitization,Quantitative risk assessment,Plant protection products
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