EMA - Update Appendix 3: Enhanced Ames Test conditions for N-nitrosamines

Hi Lucas, thanks for the remark!
This was already on previous version (EMA/451666/2023, 12 October 2023)

We can refer to previous related post :slight_smile:
:eu: EMA - Enhanced AMES test conditions - Guidance, Documents, Resources - Nitrosamines Exchange (usp.org)

There are some difference in the wording across text e.g.

Last paragraph of page 2 “The choice of the N-nitrosamine positive controls needs to be justified based on the anticipated metabolism of the N-nitrosamine and the cytochrome P450 enzymes most likely involved. In addition, if an organic solvent is used to dissolve the test compound, it is recommended that the volume of the organic solvent employed to dissolve the N-nitrosamine positive controls, results in a
similar concentration as for the test compound in the pre-incubation mix.”
…previous ending was “pre-incubation mix, if applicable.” ("if applicable was deleted).

Any case, from my perspective “main update” is the image I shared above.

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