Statistical Analysis section of partial replicate BE study [RSABE / ABEL]

posted by cher0424 – China, 2015-01-07 06:39 (2696 d 11:24 ago) – Posting: # 14234
Views: 29,657

(edited by cher0424 on 2015-01-07 10:32)

Dear all:
I have a query concerning Statistical Analysis section of partial replicate.
There is a paragraph i quote from one of partial replicate design (EU scope) BE study protocol:
  1. The selection of 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.
  2. The Selection of subjects who completes at least two periods with at least one test and one reference treatment of the subject will be considered for Bioequivalence
  3. The subjects who complete minimum of two periods with two references in the study will be included in the statistical analysis to estimate within-subject variability of the reference product (SWR).
It is resonable? Or where is these refer from??

Thanking you advance!!!!!


Edit: Category changed. [Helmut]

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