Bioequivalence and Bioavailability Forum • If we have any methods to widen CI in parallel design with high variance drug?

libaiyi
★

China,
2021-02-02 10:39
(1446 d 10:55 ago)

Posting: # 22199
Views: 3,345

If we have any methods to widen CI in parallel design with high variance drug? [RSABE / ABEL]

Dear all,

Recently I meet a problem about sample size of high variance drug, normally, we will design a repeated cross-over trial for this kind of drug. But this time it is designed as a parallel study due to some reasons. But the sample size is too much based on 80%-125% BE CI. So my quesion is if we have any method to widen the CI like RSABE in cross-over study? Thank you very mcuh. :-D

Sincerely,
libaiyi

ElMaestro ★★★ Denmark, 2021-02-02 12:12 (1446 d 09:22 ago) @ libaiyi Posting: # 22200 Views: 2,630	If we have any methods to widen CI in parallel design with high variance drug? Post reply
	Hi libaiyi, ❝ (...) So my quesion is if we have any method to widen the CI like RSABE in cross-over study? I don't think there is any authority generally willing to widen the acceptance range in parallel trials involving humans (they'd perhaps do it if you were studying pMDI's in vitro etc). — Pass or fail! ElMaestro

libaiyi ★ China, 2021-02-02 12:40 (1446 d 08:54 ago) @ ElMaestro Posting: # 22201 Views: 2,644	If we have any methods to widen CI in parallel design with high variance drug? Post reply
	Get it! Thank you Sir! Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]