Two tests and one reference [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2018-06-26 15:13 (2102 d 01:01 ago) – Posting: # 18967
Views: 12,738

Hi libaiyi,

❝ […] the goal is to prove the equivalence of any two of them (T1 and R or T2 and R). Will the CI still determined as 95% or 90%?


If this is a pivotal study (say you want to demonstrate BE of a capsule (T1) and a tablet (T2) to R which is either a tablet or a capsule) IMHO, you should employ Bonferroni’s 95% which preserves the familywise error rate at 1-(1-0.05/2)2=4.9375%. Reason: When both products are approved, based on ABE a patient my switch from R to T1 or from R to T2.
Slightly off topic: Another story would be one test and two references of different regions. If we ignore tourists, we have two different populations of patients. Then we don’t have to adjust α and go with the 90% CI.

❝ I also want to know how to select the suitable design between latin squares and William design when there exists three treatment, R T1 T2.


That’s a matter of taste. Williams’ designs are variance-balanced even for carryover (which is not part of the model). Hence, some people (see there) prefer them over Latin Squares. BTW, the EMA’s GL states the six-sequence Williams’ design for the story mentioned above.
More important than the design is the evaluation (see this post).

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
72 visitors (0 registered, 72 guests [including 11 identified bots]).
Forum time: 15:14 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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