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RegisterDose-dependent PK [General Statistics]
posted by Helmut 
– Vienna, Austria, 2011-11-02 23:30 (4932 d 04:21 ago) – Posting: # 7590
Views: 8,111
Dear ElMaestro!
Yes. I’m aiming at a confirmatory study – not the stuff mentioned in the GL (“If you come up with some serious writing about the drug’s PK from the Library of Alexandria – whether it might be on parchment or papyrus – we accept that and you have to perform the study on the highest dose only.”)
I’m not happy with assessing dose-proportionality based on Cmax. It’s a f**g composite metric.
I prefer AUC by far.
Yeah, that’s funny reading matter. Should read the talk-page as well.
❝ At least for EU, I guess part of the story is to live with the BE-guideline's requirement "Assessment of linearity will consider whether differences in dose-adjusted AUC meet a criterion of ± 25%." which can be dealt with very simply.
❝ Perhaps your angle is different and that where the complexity comes in? I am eager to hear.
Yes. I’m aiming at a confirmatory study – not the stuff mentioned in the GL (“If you come up with some serious writing about the drug’s PK from the Library of Alexandria – whether it might be on parchment or papyrus – we accept that and you have to perform the study on the highest dose only.”)
❝ […] Cmax etc vs dose being a straight line, I am perfectly willing to call that linearity;
I’m not happy with assessing dose-proportionality based on Cmax. It’s a f**g composite metric.
I prefer AUC by far.
❝ Wikipedia does an excellent job at confusing readers.
Yeah, that’s funny reading matter. Should read the talk-page as well.
—
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:
- Two-stage (any method) and multiplicity Helmut 2011-10-30 17:36 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Two-stage (any method) and multiplicity ElMaestro 2011-10-30 18:26
- Dose-dependent PKHelmut 2011-11-02 22:30
- Dunnett not for continuous scales? Really? d_labes 2011-11-01 11:11
- Yes, yes – but another construction site Helmut 2011-11-02 22:18
- PowerTOST help d_labes 2011-11-03 13:18
- PowerTOST help (solved) Helmut 2011-11-03 14:28
- intersection-union test martin 2011-11-03 22:28
- IUT and Dunnett: code for comparison of power martin 2011-11-05 23:43
- PowerTOST help d_labes 2011-11-03 13:18
- Yes, yes – but another construction site Helmut 2011-11-02 22:18
- Two-stage (any method) and multiplicity ElMaestro 2011-10-30 18:26
Ing. Helmut Schütz