Read-across/SAR posts Collection

Limits of Nitrosamines
2
  1. Update of the CMDh’s Q&A Document on Nitrosamine Impurities January 2022

@conudel pointed out lots of problems with guidance. We don’t have clear guidance on how to perform acceptable QSAR/read-across analysis to set acceptable intakes; the molecular weight adjustment method is not yet accepted; the criteria for the selection of adequate surrogates for the read-across method is not clear.

  1. N-nitroso-propranolol? March 2022
    Fantastic literature “Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities” was firstly introduced on this topic. But I am sorry whether this approach can apply to your nitrosamines is not clear.
  1. Using SAR to evaluate hazard and potency (Recording) June 2022
    @Naiffer_Host shared the recording of @David’s presentation, "How Concerning is your nitrosamine? Using SAR to evaluate hazard and potency”
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