Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs

Guidance, Documents, Resources
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Medicines for europe published the document.
https://www.medicinesforeurope.com/2023/10/30/1-why-clarification-harmonisation-of-the-bolar-exemption-and-an-explicit-prohibition-of-patent-linkage-is-needed-in-the-european-union/

The purpose of the report is to consider the 5 following topics.

  1. Exemplar nitrosamine compounds to test rela􀆟ve potency between in vivo muta􀆟on and cancer.
  2. Inves􀆟gate whether NDSRIs have low or no potency and could be considered as non-cohort of concern (non-CoC).
  3. Inves􀆟gate using in vivo muta􀆟on BMD CI for rela􀆟ve potency assessment to further inform on potency categorisa􀆟on (EMA #1-5).
  4. Comparisons with levels in food.
  5. 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!!

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A big read, but a big topic, and well worth it.

It will be fascinating to see where some of this work leads us in the understanding of the limits that should be applied to nitrosamines, and a step forward for science.

Looking forward to seeing the papers that seem to be in the pipeline, and how they are accepted by authorities.

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