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This is further differentiated based on phase:

1 For Phase 1 studies of 14 days or less, the guidance defines the need to provide a description of efforts to mitigate risks of mutagenic impurities focused on Class 1 and Class 2 impurities and those in the cohort of concern.

2 For Phase 1 clinical trials greater than 14 days and for Phase 2a clinical trials, it states that in addition Class 3 impurities that require analytical controls should be included.

3 For Phase 2b and Phase 3 clinical development trials, a list of the impurities assessed by (Q)SAR now should be included, as well as a description of the systems used. Any Class 1, 2, or 3 actual and potential impurities should be described along with details as to how they are controlled. The results of bacterial mutagenicity tests should also be reported.

It is also stated that chemistry arguments may be used in lieu of analytical data for potential impurities that present a low likelihood of being present; this represents in effect Option 4 control. It is assumed therefore that this is applicable irrespective of the phase, despite this not being specifically stated.