Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

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.
Source: Regulatory Toxicology and Pharmacology - Category: Toxicology Source Type: research