Subjects in replicate BE study EU/FDA [RSABE / ABEL]

posted by Relaxation  – Germany, 2015-03-02 09:46 (2642 d 08:49 ago) – Posting: # 14520
Views: 26,463

Dear all.

Sorry for bringing this thread back to life instead of creating a new one, but as I only think I want to point on one thing, this seemed more appropriate to me.
It was here stated twice that

» To state it briefly:
» – samples from subjects who complete at least 2 periods will be analysed
» – subjects who has 2 periods of R will be included to determine Swr
» – subject who can provided at least one T and one R will be included for BE evaluation
» The last 2 is "done automatically" as Detlew said but I would prefer to state it very clearly in the protocol just in case. ;-)

and I am not sure, whether I miss something here. From my experience, including the sample data set of the EMA-PKWP, there is no automatism for these subjects, even in case the "method A" / GLM object is used.
In other words, subjects with missing data will be included in the evaluation unless we exclude them by selection.

As a quick example (method A on the EMA dataset I (?, the 4 period one))
Original result:
115.66 (107.11-124.97)
Incomplete subjects excluded by hand:
115.46 (106.49-125.19)
[no 11/20/24/31/42/67/69/71] --> no automatic excludion of incomplete data sets
For the show, subject 100 with R twice with values of 1000 and 500 added:
112.21 (1.16-10833.43)
--> even subjects without data for a T vs R comparison have an impact (choosing such values for ln(data) was a little bit too much but is nicely illustrating, isn't it).

So also subjects with missing periods including those with Reference Data only will remain in the evaluation if we simply use the code and, if wanted, subjects have to be excluded manually beforehand (which for BE assessment seems to be acceptable with EMA only for those with Reference only).

Sorry, if I missed somethin and this is a triviality :-D. Then feel free to simply ignore the post :-(. Just wanted to add these piece of info to the "automatic"-statements.

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