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RegisterEMA MR Draft Guidelines Application [Regulatives / Guidelines]
Dear John and Helmut,
Thank you for your reply.
Any idea about which truncation point to be considered for pAUC?
As pAUC is considered to be more variable as compared to Cmax and AUC. Thus should Sample Size be considered accourdingly? And if it is to be considered more subjects may be required. And for pAUC which literature should we consider for calculation of Sample Size?
Regards,
Jay
Thank you for your reply.
❝ Why not? The problems start with the truncation time point (which has to be prespecified). I guess I will not have been the only one objecting against τ/2. The first pAUC might be highly variable (though widening of the acceptance range might be possible if the study was performed in a replicate design). If in doubt, go for a scientific advice.
Any idea about which truncation point to be considered for pAUC?
As pAUC is considered to be more variable as compared to Cmax and AUC. Thus should Sample Size be considered accourdingly? And if it is to be considered more subjects may be required. And for pAUC which literature should we consider for calculation of Sample Size?
Regards,
Jay
Complete thread:
- EMA MR Draft Guidelines Application Jay 2013-09-16 15:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA MR Draft Guidelines Application jag009 2013-09-16 17:30
- EMA MR Draft Guidelines Application Helmut 2013-09-17 13:35
- EMA MR Draft Guidelines ApplicationJay 2013-12-23 11:00
- EMA MR Draft Guidelines Application Helmut 2013-12-23 13:54
- EMA MR Draft Guidelines Application Jay 2013-12-23 14:54
- Science first! Helmut 2013-12-23 15:41
- EMA MR Draft Guidelines Application Jay 2013-12-23 14:54
- EMA MR Draft Guidelines Application Helmut 2013-12-23 13:54
- EMA MR Draft Guidelines ApplicationJay 2013-12-23 11:00
Ing. Helmut Schütz