Full replicate designed study for Europe [RSABE / ABEL]

posted by bebac_fan – US, 2018-04-01 04:45 (1591 d 17:40 ago) – Posting: # 18626
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Hi Balakotu,

» Here my question is whether to include the subjects who completed at least one test and one reference for bio-equivalence calculation?

I do not work with EMA so I am unable to provide any empirical evidence. However, you may check the EMA guidance
here. Page 14 of the guidance states "...subjects in a
crossover trial who do not provide evaluable data for both of the test and reference products ...should not be included. "

With FDA, the safe route would be to provide statistical analysis with and without exclusions (especially if they both pass :cool:).

I have seen some discussions around regarding drop-outs in replicate studies. Perhaps this implies that subjects aren't evaluable if they don't complete all 4.

Follow up question for the pros: if you include partially completed subjects, does this unbalancing have an effect on the mixed model?

I guess you lose a df if you have a subject that only had RR or TT, so I understand that. But what about a subject that has TR (instead of TRTR).

Cheers,
BF

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