EU: no re-dosing [Outliers]

posted by swapnil.kuche – 2011-03-10 07:39 (4471 d 12:55 ago) – Posting: # 6735
Views: 7,224

Dear HS,

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.


Edit: Original quote restored. [Helmut]

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