Assertion: impurity's level | /r/HasProperty | justified
Facets:
value: based on duration of exposure
type: OTHER
Source sentences:
text: A level of a qualified impurity higher than that present in a new drug substance can also be justified based on an analysis of the actual amount of impurity administered in previous relevant safety studies.
text: In those cases where carcinogenicity data are not available, the TTC is applied by default unless the applicant can demonstrate that higher levels are justifiable based on duration of exposure or based on preexisting exposure, e.g. via foodstuffs.
text: The level of any impurity present in a new drug substance that has been adequately tested in safety and/or clinical studies would be considered qualified.