From TD50 to Benchmark Dose in Nitrosamine Risk Assessment: Evidence from N-Nitrosotrimetazidine Carcinogenicity and TGR Mutation Data.
The presence of N-nitrosamine drug substance-related impurities (NDSRIs) in pharmaceuticals represents a significant regulatory and safety challenge due to their classification as "cohort of concern" compounds. This paper describes the toxicological evaluation of N-Nitrosotrimetazidine (NTMZ), performed to refine the initial default acceptable intake (AI) limits of 18 to 26.5 ng/day established…
We haven't written up this one. bioRxiv has the full story — the link below goes straight to it.
