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RegisterReanalysis for PK Reason: Gone with the Wind [Bioanalytics]
Hi dshah
» If we are focusing on root cause, I believe that for pre-dose concentration even in period-I would not cause a significant issue to final BE out come as it may only impact AUC and it would not be significant.
If the value is MT 5% of Cmax, the subject would by default not considered for statistical evaluation 
.
How can you be so sure that its effect on AUC won't be significant? The removal/or inclusion of a subject from a statistical evaluation is enough is change the outcome especially if the result is borderline.
» If we are focusing on root cause, I believe that for pre-dose concentration even in period-I would not cause a significant issue to final BE out come as it may only impact AUC and it would not be significant.
If the value is MT 5% of Cmax, the subject would by default not considered for statistical evaluation . How can you be so sure that its effect on AUC won't be significant? The removal/or inclusion of a subject from a statistical evaluation is enough is change the outcome especially if the result is borderline.
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Ing. Helmut Schütz