Statistical evaluation and BE hypo­theses in full replicate design [RSABE / ABEL]

posted by Elena777 – Belarus, 2020-01-28 08:02 (1989 d 17:43 ago) – Posting: # 21090
Views: 30,386

Dear All,

Is it OK to use the following approach of statistical evaluation in a BE study with full replicate design:
  1. Average bioequivalence is used to determine bioequivalence first.
  2. If bioequivalence is not met for Cmax, scaled-average-bioequivalence can be used if both of the following conditions are met:
    • the point estimate of the geometric mean ratio lies within the 80.00-125.00% range;
    • the R-R within-subject CV is > 30%, and is not the result of outliers?
And another question: is this obligatory to include the detailed description of null and alternative hypotheses for Cmax (ABEL) and AUCt (ABE) together with description of conditions that lead to acceptance/rejection of a hypothesis in a protocol of a full replicate study?

Edit: Category changed; see also this post #1. [Helmut]

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