## Suggested: TRT|RTR [RSABE / ABEL]

Hi Sundar,

» […] advantages/disadvantages of following 6 sequences (TRR, RTR, RRT, RTT, TRT and TTR) in a RSABE design, instead of 3 sequences as per FDA recommendations.

• Additionally to the estimate of CVwR you get the one of CVwT (good to know esp. if your study is a pilot and you want to design a pivotal study where CVwR ≠ CVwT). In the partial replicate you have to assume that CVwR = CVwT.
• If swR <0.294 (only ABE acceptable) no convergence issues in the mixed-effects model with the FDA’s covariance-specification.
• Sample size is a multiple of six (instead of three in the partial replicate and two in the three-period full replicate).
• Design currently not implemented in PowerTOST’s function sampleN.RSABE().
If you want to kill two birds with one stone I recommend the three-period two-sequence full replicate design (TRT | RTR) instead.

Dif-tor heh smusma 🖖
Helmut Schütz

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