Full replicate designed study for Europe [RSABE / ABEL]

posted by balakotu – India, 2018-03-31 11:59  – Posting: # 18625
Views: 1,393

Dear Members,
I need some suggestion regarding full replicate study statistical data analysis for Europe scope. Study conducted in four period full replicate design. Majority of the subjects completed all four period of the study and some subjects completed at least two periods with one test and one reference treatments.
The subjects with at lease two reference treatments included in calculation of ISCVR.
The study showing more than 30% ISCVR. The study eligible for scaled average bio equivalence approach. (widening criteria for Cmax). The subjects who completed all four periods will be included in PK and Stats. Here my question is whether to include the subjects who completed at least one test and one reference for bio-equivalence calculation?

Thanks and regards

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