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RegisterTwo-stage (any method) and multiplicity [General Statistics]
Dear HS,
There are quite a few SPC's out there which state dose proportionality or dose linearity and where the originator as far as I know hasn't really done that fancy stuff but just administered a series of doses and checked AUC or Cmax or Cl. That's good enough isn't it.
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.
Btw, in spite of the links to previous definitions and discussions I still think we need some useful definitions, preferably in guidelines. Cmax etc vs dose being a straight line, I am perfectly willing to call that linearity; Wikipedia does an excellent job at confusing readers.
❝ Opinions, ideas?
There are quite a few SPC's out there which state dose proportionality or dose linearity and where the originator as far as I know hasn't really done that fancy stuff but just administered a series of doses and checked AUC or Cmax or Cl. That's good enough isn't it.
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.
Btw, in spite of the links to previous definitions and discussions I still think we need some useful definitions, preferably in guidelines. Cmax etc vs dose being a straight line, I am perfectly willing to call that linearity; Wikipedia does an excellent job at confusing readers.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 multiplicityElMaestro 2011-10-30 18:26
- Dose-dependent PK Helmut 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 multiplicityElMaestro 2011-10-30 18:26
Ing. Helmut Schütz