TRR / RTT Design [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2017-05-09 13:06  – Posting: # 17333
Views: 5,519

Hi Yura,

» What if the design of the TRR / RTT obtained by Cmax
» CI T-R = 0.88-1.21;
» CV T-R =48%;
» expansion [0.71-1.40] CV R-R=47%;

Fulfills all requirements for ABEL: CVwR >30%, CI within expanded limits, and PE within 0.8000–1.2500.
Following the ‘logic’ of the EMA’s Q&A document at least 12 subjects should have finished the sequence TRR in order to get a ‘reliable’ estimate of CVwR. I guess that the sample size was 34, right?
If an assessor does not accept this design (not mentioned in the Q&A…) the study demonstrated even ABE.

» GMR T-T=0.708 not belong [0.80; 1.25];
» CI T-T = 0.47-1.06;
» CV T-T =77%.
» Is it possible to draw a conclusion about bioequivalence?

Yes. By definition BE is the (desired) outcome of a comparison of T with R.
The results of T vs. T are interesting but not relevant. BTW, how did you calculate the GMR and the CI? IMHO, if you use only the data of the sequence RTT (as for CVwT) you can evaluate it only as a paired design (e.g., arbitrarily comparing data of the second administration to the first). Such an evaluation assumes no period effects – which might be false.

Cheers,
Helmut Schütz
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