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RegisterProtocol / SAP? [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2016-03-15 15:32 (3748 d 21:04 ago) – Posting: # 16105
Views: 7,384
Dear Dan & Rams,
Given the results, yes.
@Rams (nitpicking): 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?
BTW, I assume that you are referring to arithmetic means? False for PK metrics following a discrete distribution (tmax); use medians instead. False for t½ as well; best would be harmonic means followed by geometric means.
❝ So everything is fine.
Given the results, yes.
@Rams (nitpicking): 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?
BTW, I assume that you are referring to arithmetic means? False for PK metrics following a discrete distribution (tmax); use medians instead. False for t½ as well; best would be harmonic means followed by geometric means.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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