Confidence interval between two study for same test and reference lot [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2021-08-04 21:41 (52 d 08:31 ago) – Posting: # 22508
Views: 954

Hi RG628,

» We conducted two BE study for one of the ANDA, in one study we got 90% CI (77-108) and another study we got (106-125.8) for same test and RLD lot. Will it possible to combine both study two justify product is bio-equivalent based on observe variability for regulatory submissions.

Very unfortunate.
I would check first if T and R were by coincidence switched somehow in the evaluation. I.e. if you had a 90% CI for T/R of 77-108 in one study, and then got a CI of 106-126 for R/T (rather than T/R) in the next. This would be consistent.
Such an issue could for example be related to treatment coding and alphabetical order etc. If T and R were called T and R in one study, but A and B in the other, and if both datasets were evaluated with the same script then strange things could happen depending on how the scripts were written.

I know this is a long shot from my side and I hope it does not offend you that I am mentioning it as a potential cause for a surprising observation. I can only confess that this is the type of mistake I could so easily make myself.

Pass or fail!

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