Subjects to be considered in partial replicate BE study [RSABE / ABEL]

posted by cher0424 – China, 2015-01-08 09:51 (2725 d 01:35 ago) – Posting: # 14249
Views: 27,225

Dear Detlew

Sorry to ask again, but I can't see any contradiction between point 1 and 3.
And to point 1 and 2, subjects who complete at least two periods with at least one test and one reference treatment of the study will be included in the pharmacokinetic and statistical analysis,so then can be considered for Bioequivalence.

Is it causal relationship between 1 and 2??
And do you know any literature about statistical analysis of partial replicate BE study?

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