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2.4.7.1 Question 7.1
ОглавлениеThis question relates to the same paragraph from the guideline that was stated above in Question 6.4.
| Question | Answer |
|---|---|
| If an Ames positive impurity is subsequently tested in an appropriate in vivo assay and the results are clearly negative, is that sufficient to demonstrate lack of in vivo relevance? | Yes. A well‐conducted and scientifically justified in vivo study (see Question 6.4 in this document) is sufficient to demonstrate lack of in vivo mutagenic relevance. If the results of the in vivo study are clearly negative, the impurity can be assigned to ICH M7, Class 5. |
This Q&A almost states the obvious. The entire intention of Note 3 in the guideline is to provide adequate in vivo tests that can overrule a positive Ames test, and if an impurity is determined to be nonmutagenic, then it can be considered a Class 5 impurity.
