FDA RSABE is ISC [R for BE/BA]

posted by d_labes  – Berlin, Germany, 2020-07-15 18:13 (560 d 05:13 ago) – Posting: # 21703
Views: 13,363

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

Complete thread:

Activity
 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 24 (0 registered, 24 guests [including 12 identified bots]).
Forum time: Wednesday 22:26 CET (Europe/Vienna)

The real purpose of the scientific method is to make sure
nature hasn’t misled you into thinking you know something
you actually don’t know.    Robert M. Pirsig

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5