Log in
RegisterProtocol / SAP? [Study Assessment]
Dear Helmut,
Thank you for writing. in protocol we have included PK parameters are Cmax, AUCt and AUCinf not represented AUC0-72 however our sampling is up to 72 hours only. so that i have a doubt do we hav to confirm or not wether the AUCt covers at least 80% AUCinf.
Thanks & regards,
Rams
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
❝ Since you were aware that truncating the AUC is acceptable in most regulations nowadays, why did you calculate AUC0–∞ (and the fraction covered by AUC0–72) at all? What does your protocol / SAP say?
Thank you for writing. in protocol we have included PK parameters are Cmax, AUCt and AUCinf not represented AUC0-72 however our sampling is up to 72 hours only. so that i have a doubt do we hav to confirm or not wether the AUCt covers at least 80% AUCinf.
Thanks & regards,
Rams
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Complete thread:
- if 75% of the subjects AUCt not covers at least 80% of AUCinf rams 2016-03-15 06:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- if 75% of the subjects AUCt not covers at least 80% of AUCinf Dr_Dan 2016-03-15 08:49
- Protocol / SAP? Helmut 2016-03-15 14:32
- Protocol / SAP?rams 2016-03-23 05:31
- Protocol / SAP? Helmut 2016-03-15 14:32
- if 75% of the subjects AUCt not covers at least 80% of AUCinf Ohlbe 2016-03-23 09:44
- if 75% of the subjects AUCt not covers at least 80% of AUCinf Dr_Dan 2016-03-15 08:49
Ing. Helmut Schütz