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Regul. Toxicol. Pharmacol. · Apr 2019
ReviewShort commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products.
- David J Snodin and David P Elder.
- Xiphora Biopharma Consulting, Bristol, UK. Electronic address: snodind@xiphora.com.
- Regul. Toxicol. Pharmacol. 2019 Apr 1; 103: 325-329.
AbstractA 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.Copyright © 2019 Elsevier Inc. All rights reserved.
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