Sample size taking into account SbF [Power / Sample Size]

posted by d_labes  – Berlin, Germany, 2016-07-13 15:49 (3138 d 13:14 ago) – Posting: # 16486
Views: 6,414

Dear Junhao,

❝ 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 :-D.

❝ In a previous post, A reference is mentioned:

❝ ...

❝ A link was given below but I failed opening it :lookaround:. 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

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