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RegisterPharmacokinetic calculation in missing samples [Study Assessment]
Dear all
In a two way, single-dose bioequivalence study,we have two subjects missing 3-4 samples in the elimination phase for only one period. Hence in this case when we calculate AUCt, there is going to be an under estimation for AUC of product taken during the missed samples period. I would like to know how to proceed further? should we trucate to equal time points in both periods or drop the complete data of two subjects from the analysis?
Kindly let me know if any regulatory agency has defined the same
Edit: Category changed. [Helmut]
In a two way, single-dose bioequivalence study,we have two subjects missing 3-4 samples in the elimination phase for only one period. Hence in this case when we calculate AUCt, there is going to be an under estimation for AUC of product taken during the missed samples period. I would like to know how to proceed further? should we trucate to equal time points in both periods or drop the complete data of two subjects from the analysis?
Kindly let me know if any regulatory agency has defined the same
Edit: Category changed. [Helmut]
Complete thread:
- Pharmacokinetic calculation in missing samplesdrplacebo 2008-11-10 09:05
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Ing. Helmut Schütz