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RegisterSample size partial replicate design: df [Regulatives / Guidelines]
Dear Helmut!
THX for the reference. But the power/sample size is unfortunately for IBE, although with sigmaD=0. This is ABE?
Moreover my glasses are not strong enough
for the very, very small tables in the online resource.
Meanwhile I have tried to derive the degrees of freedom (df) and design constant by myself (in the same manner as in Chow, Liu "Design and Analysis of Bioavailability and Bioequivalence Studies", chapter 9.
Here the results (without carry-over) for the df:
n is the total number of subjects (n1+n2+n3 with ni=number of subjects in sequence i).
As can be seen the intra-subject residual df are the same as for the 2x2x3 design (TRR/RTT or TRT/RTR).
For the design constant my brain is not big enough today.
But my believe is: it is also the same as for the 2x2x3 if we do not consider carry-over.
If yes than we can use the results for the sample size of the 2x2x3 design for that of a partial replicate design and you are fully 'rehabilitated'
.
Someone out there to prove me wrong?
THX for the reference. But the power/sample size is unfortunately for IBE, although with sigmaD=0. This is ABE?
Moreover my glasses are not strong enough
for the very, very small tables in the online resource.Meanwhile I have tried to derive the degrees of freedom (df) and design constant by myself (in the same manner as in Chow, Liu "Design and Analysis of Bioavailability and Bioequivalence Studies", chapter 9.
Here the results (without carry-over) for the df:
source of variation df
--------------------------
inter-subject n-1
sequence 2
residual n-3
--------------------------
intra-subject 2*n
period 2
formulation 1
residual 2*n-3
--------------------------
total 3*n-1
--------------------------n is the total number of subjects (n1+n2+n3 with ni=number of subjects in sequence i).
As can be seen the intra-subject residual df are the same as for the 2x2x3 design (TRR/RTT or TRT/RTR).
For the design constant my brain is not big enough today.
But my believe is: it is also the same as for the 2x2x3 if we do not consider carry-over.
If yes than we can use the results for the sample size of the 2x2x3 design for that of a partial replicate design and you are fully 'rehabilitated'
.Someone out there to prove me wrong?
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Scaled Average Bioequivalence graveendranath 2010-01-06 07:36 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- RSABE (EU) Helmut 2010-01-06 17:01
- RSABE (EU) d_labes 2010-01-07 09:14
- RSABE (EU) Helmut 2010-01-07 13:21
- Sample size partial replicate design d_labes 2010-01-07 13:56
- Sample size partial replicate design Helmut 2010-01-07 14:23
- Sample size partial replicate design: dfd_labes 2010-01-07 16:21
- Sample size partial replicate design: variance d_labes 2010-01-08 10:37
- Sample size partial replicate design Helmut 2010-01-07 14:23
- Sample size partial replicate design d_labes 2010-01-07 13:56
- RSABE (EU) Helmut 2010-01-07 13:21
- RSABE (EU) d_labes 2010-01-07 09:14
- RSABE (EU) Helmut 2010-01-06 17:01
Ing. Helmut Schütz