Bioequivalence and Bioavailability Forum

Dear Junhao,

❝ In Table 1, Appendix C of FDA 2001 guidance Statistical Approaches to Establishing Bioequivalence, the sample size is calculated for different σ_Ds. ...

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 σ_D, 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 σ_D, or the σ_D 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.