Medicines for europe published the document.
The purpose of the report is to consider the 5 following topics.
- Exemplar nitrosamine compounds to test relave potency between in vivo mutaon and cancer.
- Invesgate whether NDSRIs have low or no potency and could be considered as non-cohort of concern (non-CoC).
- Invesgate using in vivo mutaon BMD CI for relave potency assessment to further inform on potency categorisaon (EMA #1-5).
- Comparisons with levels in food.
- Considering the AI from EMA, USFDA and Health Canada calculated using the CPCA approach.
This includes novel and useful information to understand the toxicity of NDSRIs. Please check it!!