FDA RSABE is ISC [🇷 for BE/BA]

posted by d_labes  – Berlin, Germany, 2020-07-15 20:13 (2161 d 21:09 ago) – Posting: # 21703
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Hi Helmut, Hi ElMaestro,

❝ ...

❝ Well, the EMA’s models are wacky because they assume equal intra-subject variances of T and R. An assumption which was shown to be false in many cases. Essentially most of the information obtainable in a replicate design is thrown away.


Full ACK!

❝ I don’t know why the FDA does not directly estimate \(\small{s_\textrm{wR}^2}\) from the mixed model but work with the intra-subject contrasts of R instead. ...


I was always wondering about the different methodologies in the code of the progesteron guidance:
Why not use the ISC estimate of T-R in the ABE decision in case of swR < 0.029356 (CVwR < 30%)?
Politics? Nostalgia (Since years recommended the Proc MIXED code)?

Or the other way round: Why not use the components of the RSABE criterion (pe and 90% CI, s2wR) from the mixed model approach?

I would opt for the full ISC approach because it may be unambiguously implemented in SAS, R, Phoenix and so on for every replicate design, full or partial :cool:.
—
Regards,

Detlew

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