Bioequivalence and Bioavailability Forum 01:38 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

BE study stratified per body weight group [General Sta­tis­tics]

posted by martin - Austria, 2018-06-08 09:15  - Posting: # 18867
Views: 635

Dear all,

I am facing an interesting BE study and would be happy to get the forum members thoughts on the analysis strategy

Background: one reference (R) and two test items (T1, T2) with different doses per body weight stratum

Body weight stratum 1: x mg for T1, T2 and R for subjects < z kg
Body weight stratum 2: y mg for T1, T2 and R for subjects > z kg

Study design: Williams’ design (3-treatment, 3-period, 6-sequence) with stratified randomization according to body weight stratum (<z kg and > z kg) to ensure balance regarding this strata.

Questions:

1) Can the BE assessment be based on all data combined or does this require a separate analysis per body weight stratum

2) If a combined assessment is the way to go how should the model look like

a) Ignoring body weight strata and use classical model (FDA): fixed effects for period, sequence, treatment and random effect for subject nested in sequence.

b) Including body weight strata as mentioned in ICH E9 (i.e. factors on which randomization has been stratified should be accounted for later in the analysis): fixed effects for period, sequence, treatment, body weight strata and random effect for subject nested in sequence.

Best regards and looking forward to an interesting discussion

Martin


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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,698 posts in 3,983 threads, 1,234 registered users;
online 8 (0 registered, 8 guests [including 8 identified bots]).

When puzzled, it never hurts to read the primary documents –
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed