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RegisterSample size dosage strength proportionality study [Power / Sample Size]
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,
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,
Complete thread:
- Sample size dosage strength proportionality studyLaura R 2021-02-01 09:19 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Modified acceptance range, confirmatory vs. exploratory Helmut 2021-02-01 11:34
- Modified acceptance range, confirmatory vs. exploratory Laura R 2021-02-02 18:03
- Modified acceptance range, confirmatory vs. exploratory Helmut 2021-02-01 11:34
Ing. Helmut Schütz