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

posted by Laura R  – Israel, 2021-02-01 10:19 (1121 d 04:13 ago) – Posting: # 22197
Views: 2,027

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.

Best,

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