Log in
RegisterReference Scaled approach [RSABE / ABEL]
Dear All,
In the recent development by FDA on highly variable (HVD) a reference scaling approach has been suggested as mentioned in the paper by Sam H.Haidar. In this of the different approaches method 2 has been found to be acceptbale to FDA.
For Reference scaling approach we need partial replicate design where T is given once and R is given twice
In this the calculation is done using the formula
UT-UR^2 / Sigmawr^2 < theta
we have calculated the UT and UR and theta.
Sigmawr is the estimated within subject standard deviation (estimated from the ANOVA on the log scale)
My question is - Since we have two set of data for R, which data set should be used to calculated Sigmawr. Either of them can be used or we have to take average of both the sets.
Pl clarify.
Thanks and Regards
Chirag Khatri
--
Edit: Category changed. [Helmut]
In the recent development by FDA on highly variable (HVD) a reference scaling approach has been suggested as mentioned in the paper by Sam H.Haidar. In this of the different approaches method 2 has been found to be acceptbale to FDA.
For Reference scaling approach we need partial replicate design where T is given once and R is given twice
In this the calculation is done using the formula
UT-UR^2 / Sigmawr^2 < theta
we have calculated the UT and UR and theta.
Sigmawr is the estimated within subject standard deviation (estimated from the ANOVA on the log scale)
My question is - Since we have two set of data for R, which data set should be used to calculated Sigmawr. Either of them can be used or we have to take average of both the sets.
Pl clarify.
Thanks and Regards
Chirag Khatri
--
Edit: Category changed. [Helmut]
Complete thread:
- Reference Scaled approachchiragkhatri 2009-05-22 13:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reference Scaled approach Ravi 2009-05-23 06:40
Ing. Helmut Schütz