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

posted by Elena777 – Belarus, 2020-01-28 07:02 (879 d 23:54 ago) – Posting: # 21090
Views: 20,203

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:

UA Flag
Activity
 Admin contact
22,167 posts in 4,645 threads, 1,572 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Sunday 07:57 CEST (Europe/Vienna)

The person interested in success has to learn
to view failure as a healthy, inevitable part
of the process of getting to the top.    Joyce Brothers

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