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RegisterWhat to do with Whole period (Test or reference) is zero [Regulatives / Guidelines]
Hi Mohamed,
Tricky question. The concentrations are not 0, they are just under the LLOQ, so you may impute the values as missing, 0 or 1/2 of the LLOQ. Therefore, depending on the method, you would be able to use the subject in the statistical analysis at least for Cmax and AUC0-t. But I think it's a bit odd. Would be very glad to know what the experts of the forum think about this subject. I imagine that such an occurrence might be very rare and should be further explored with the clinical team (for instance, have the subject really taken the pills?). If I was responsible for reviewing the dossier for this study, I would surely recommend an inspection
Regards,
David
Tricky question. The concentrations are not 0, they are just under the LLOQ, so you may impute the values as missing, 0 or 1/2 of the LLOQ. Therefore, depending on the method, you would be able to use the subject in the statistical analysis at least for Cmax and AUC0-t. But I think it's a bit odd. Would be very glad to know what the experts of the forum think about this subject. I imagine that such an occurrence might be very rare and should be further explored with the clinical team (for instance, have the subject really taken the pills?). If I was responsible for reviewing the dossier for this study, I would surely recommend an inspection
Regards,
David
Complete thread:
- What to do with Whole period (Test or reference) is zero Mohamed Yehia 2017-12-13 16:37 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- What to do with Whole period (Test or reference) is zeroDavidManteigas 2017-12-13 16:51
- What to do with Whole period (Test or reference) is zero mittyri 2017-12-16 22:44
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