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RegisterOutliers US FDA submission [Outliers]
Dear Chiku,
On basis of common sense I imagine I would submit.
FDA's guidance suggests that outliers are caused by product failure or SxF interaction. Whatever the case here it can be argued that your product is not associated with the 'issue' the ref. suffers from.
But I'd recommend to make sure you can argue with very thorough argumentation that you have eliminated all other sources of trouble.
❝ Reference conc was detected so may be not absorbed (reference is OROS tablet). T/R for that particular subject was 1300.
❝
❝ There was no unusual observation @ clinic or bioanalytical.
On basis of common sense I imagine I would submit.
FDA's guidance suggests that outliers are caused by product failure or SxF interaction. Whatever the case here it can be argued that your product is not associated with the 'issue' the ref. suffers from.
But I'd recommend to make sure you can argue with very thorough argumentation that you have eliminated all other sources of trouble.
- audit analytics, esp. chromatography in the run associated with the outlier, plus a few normal ones for comparison.
- audit clinics, esp. CRF's relevant to the issue. If subject in question who got the ref. had a systemic AE after dosing and the PI noted it was drug related then the story would turn quite interesting.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Outliers US FDA submission Chiku 2013-03-04 11:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Outliers US FDA submission ElMaestro 2013-03-04 11:47
- Outliers US FDA submission Chiku 2013-03-04 11:56
- Outliers US FDA submissionElMaestro 2013-03-04 13:12
- Outliers US FDA submission Chiku 2013-03-04 11:56
- Outliers US FDA submission ElMaestro 2013-03-04 11:47
Ing. Helmut Schütz