Sample size taking into account SbF [Power / Sample Size]
Dear Junhao,
Don't invest too much in understanding or verifying this table.
It shows sample sizes for the so-called "individual bioequivalence" in which the SbF (subject by formulation) interaction, your σD, plays a prominent role. "Individual bioequivalence" is nowadays history only.
The code of PowerTOST is open source, means you can inspect it, either in the source code tar-ball or even without that, just typing
At the very beginning of the code there is an expression
.
Unfortunately this link doesn't function since some time ago. Further I couldn't find the reference at other places of the Inder-nett. Drop me a mail and I can send you a backup copy of this technical report. BTW: It has two parts.
Hope this helps.
❝ In Table 1, Appendix C of FDA 2001 guidance Statistical Approaches to Establishing Bioequivalence, the sample size is calculated for different σDs. ...
Don't invest too much in understanding or verifying this table.
It shows sample sizes for the so-called "individual bioequivalence" in which the SbF (subject by formulation) interaction, your σD, plays a prominent role. "Individual bioequivalence" is nowadays history only.
❝ One further question, when power.RSABE() of R package TOST is used in simulation that gives sample size for RSABE design, does it account for σD, or the σD is assumed to be zero?
The code of PowerTOST is open source, means you can inspect it, either in the source code tar-ball or even without that, just typing
library(PowerTOST)
power.RSABE
At the very beginning of the code there is an expression
s2D <- 0
. Guess what it means 
❝ In a previous post, A reference is mentioned:
❝ ...
❝ A link was given below but I failed opening it . Can somebody help to try if this link is still correct?
Unfortunately this link doesn't function since some time ago. Further I couldn't find the reference at other places of the Inder-nett. Drop me a mail and I can send you a backup copy of this technical report. BTW: It has two parts.
Hope this helps.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Determination of sample size including the factor of σD junhao 2016-07-08 04:34 [Power / Sample Size]
- Sample size taking into account SbFd_labes 2016-07-13 13:49
- Sample size taking into account SbF junhao 2016-07-14 05:54
- Sample size taking into account SbF d_labes 2016-07-19 09:18
- Appendix C, Table I Helmut 2016-07-19 15:07
- Appendix C, Table I d_labes 2016-07-20 11:27
- I don’t care Helmut 2016-07-20 15:45
- Appendix C, Table I d_labes 2016-07-20 11:27
- Appendix C, Table I Helmut 2016-07-19 15:07
- Sample size taking into account SbF d_labes 2016-07-19 09:18
- Sample size taking into account SbF junhao 2016-07-14 05:54
- Sample size taking into account SbFd_labes 2016-07-13 13:49