Sample size dosage strength pro­por­tion­ality study [Power / Sample Size]

posted by Laura R  – Israel, 2021-02-01 09:19 (29 d 14:44 ago) – Posting: # 22197
Views: 415

Dear Forum,
I was interesting to hear thoughts about the need to power a DP study for a 505b2:
BE between T and R will be demonstrated at one dose level. The PK of the drug is linear over the entire range however because of non-proportionality composition between T strengths we will run also a DP trial (for T only).
Power model at alpha = 0.05 will be used, so the 90% CI of the slope will be compared to the [0.80, 1.25] bounds.

Couldn't find any reference/guidance on the need to base sample size to achieve 80% or 90% power (in our case this will result in a very large study), and from review of precedents this sort of trials are many times non-powered and only descriptive.

Any comment is appreciated.


Complete thread:

 Admin contact
21,359 posts in 4,460 threads, 1,492 registered users;
online 15 (0 registered, 15 guests [including 2 identified bots]).
Forum time: Wednesday 00:04 CET (Europe/Vienna)

The art and science of asking questions
is the source of all knowledge.    Thomas Berger

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