Fed (IBD) → fasting [General Sta­tis­tics]

posted by sweiner – India, 2020-07-07 05:00 (1361 d 10:39 ago) – Posting: # 21654
Views: 6,079

Helmut, thank you very much for the reply related to the adjustment of alpha, testing of fed vs. fasted, as well as the detailed sample size discussion with R code provided.

Can you please also provide feedback on one more scenario:
6-way crossover, with the following treatments A) tablet formulation #1 fasted, B) tablet formulation #2 fasted, C) capsule formulation fasted, D) tablet formulation #1 fed, E) tablet formulation #2 fed, F) capsule formulation fed.

Is there an approach that can be used to test only the first 3 treatments (all fasted) in an interim fashion, and contingent upon the results continue to test the final 3 treatments (all fed)? We are assuming a typical Latin Square such as:

A B C D E F
B C D E F A
C D E F A B
D E F A B C
E F A B C D
F A B C D E

To allow the proposed interim analysis (all fasted), is it possible to execute only the first necessary part of the Latin Square, such as:

A B C x x x
B C x x x A
C x x x A B
x x x A B C
x x A B C x
x A B C x x

With completion of the remaining parts (all fed) after the interim analysis:

x x x D E F
x x D E F x
x D E F x x
D E F x x x
x x A B C x
F x x x D E


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
114 visitors (0 registered, 114 guests [including 7 identified bots]).
Forum time: 14:39 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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