Is there a method for replicated bioequivalence design with accordance to FDA guideline?

[chzhcpu]

Hi, Helmut01. It is a good work.
Is there a method for replicated bioequivalence data analysis with accordance to FDA guideline?
I do not find a packge doing that work.

[Helmut01]

THX!
There is no package. While it might be possible to code the RSABE-part (if s_wR ≥0.294), it is impossible to setup the mixed-effects model for ABE (if s_wR<0.294) exactly like in the FDA’s guidance.

Sorry for no better news.
Helmut

[VSLohar]

Dear Helmut01
I use the "Method.B" for BE analysis of partial replicate design.
But multiple Error occured like
Error in info.design(seqs=seqs) : At least 2 sequences required.
Exp; my data set is
subject period sequence treatment PK
1 1 RTR R 405.6
1 2 RTR T 365.9
1 3 RTR R 564.2
2 1 TRR T 415.3
.....

In my dataset has 3 sequence even those error occured as "at lease 2 sequence required".

Please suggest me, how to solve this error or correct code for partial replicate statistical analysis in R software(version 4.3.3).