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

posted by Elena777 – Belarus, 2020-01-28 07:02 (722 d 00:59 ago) – Posting: # 21090
Views: 19,424

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]

Complete thread:

Activity
 Admin contact
21,831 posts in 4,567 threads, 1,553 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Wednesday 08:02 CET (Europe/Vienna)

Research under a paradigm must be a particularly effective way
of inducing paradigm change.    Thomas S. Kuhn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5