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RegisterNonsense in Guideline(s) [Software]
posted by Helmut 
– Vienna, Austria, 2009-04-08 15:07 (6276 d 05:14 ago) – Posting: # 3501
Views: 7,837
❝ I am traveling [...]
Sayonara, NewInPK!
❝ In the meantime I'll try to rephrase my first question [...]
You guessed right: individual = patient/person/subject/volunteer/animal/borg...
❝ How can there be a geometric mean for a BE measure of a subject?
❝ One subject has only one value for a BE measure for one product.
I told you before that WinNonlin's manual only quoted FDA's guideline. The wording there is nonsense. Forget about the 'geometric mean' - what FDA means is a table of individual PK metrics (AUC, Cmax,...) and ratios like this one ...
subject test reference T/R
1 95 100 0.9500
2 97 115 0.8435
.. ... ... ......
24 118 85 1.3882... which is provided by WinNonlin.
—
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:
- BE module of WinNonlin NewInPK 2009-03-27 03:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE module of WinNonlin SDavis 2009-03-27 10:52
- BE module of WinNonlin NewInPK 2009-03-28 22:18
- BE module of WinNonlin Helmut 2009-03-30 19:04
- Fixed effects CIs d_labes 2009-03-31 08:17
- Fixed effects CIs Helmut 2009-03-31 16:38
- BE module of WinNonlin NewInPK 2009-04-08 11:55
- Nonsense in Guideline(s)Helmut 2009-04-08 13:07
- Fixed effects CIs d_labes 2009-03-31 08:17
- BE module of WinNonlin SDavis 2009-03-27 10:52
Ing. Helmut Schütz