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RegisterEU: no re-dosing [Outliers]
Dear HS,
Thanks a lot for for your prompt reply.
On review of p'cokinetic data it was observed that one of subject is showing highest T/R ratio for Cmax and AUC. So we just recalculate 90% CI by excluding that subject and those results were within acceptance limit. No specific outlier test is applied here.
Infact this is about fed biequivalence study for gastro-resistant formulation and importanly we have positive results for fasting study for the same formulation.
What should be our future strategy in the same regard.
Regards,
Swapnil
Edit: Original quote restored. [Helmut]
Thanks a lot for for your prompt reply.
❝ How did you judge that the subject was an outlier?
On review of p'cokinetic data it was observed that one of subject is showing highest T/R ratio for Cmax and AUC. So we just recalculate 90% CI by excluding that subject and those results were within acceptance limit. No specific outlier test is applied here.
Infact this is about fed biequivalence study for gastro-resistant formulation and importanly we have positive results for fasting study for the same formulation.
What should be our future strategy in the same regard.
Regards,
Swapnil
Edit: Original quote restored. [Helmut]
Complete thread:
- Handling of outlier (EU) swapnil.kuche 2011-03-09 07:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EU: no re-dosing Helmut 2011-03-09 12:40
- EU: no re-dosingswapnil.kuche 2011-03-10 06:39
- difficult to eliminate a subject ElMaestro 2011-03-10 12:20
- difficult to eliminate a subject Helmut 2011-03-10 12:39
- EU: ways out? Helmut 2011-03-10 12:29
- EU: ways out? swapnil.kuche 2011-03-11 05:26
- difficult to eliminate a subject ElMaestro 2011-03-10 12:20
- EU: no re-dosingswapnil.kuche 2011-03-10 06:39
- EU: no re-dosing Helmut 2011-03-09 12:40
Ing. Helmut Schütz