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RegisterWidening Cmax in EU [RSABE / ABEL]
posted by Clarc 
– Romania, 2013-10-24 16:55 (4220 d 02:01 ago) – Posting: # 11748
Views: 5,682
Dear All
We have to perform a bioequivalence on a HVD in EU.
The intrasubject variability in the literature is 29%, 32% and 36%.
Our statistical software doesn't permit scaling, only widening to 0.75-1.33.
The design is a fully replicated TRTR/RTRT design.
So my question is:
Can I define in the protocol a widening to 0.75-1.33, or I have to perform a reference scaled bioequivalence?
Thanks
We have to perform a bioequivalence on a HVD in EU.
The intrasubject variability in the literature is 29%, 32% and 36%.
Our statistical software doesn't permit scaling, only widening to 0.75-1.33.
The design is a fully replicated TRTR/RTRT design.
So my question is:
Can I define in the protocol a widening to 0.75-1.33, or I have to perform a reference scaled bioequivalence?
Thanks
—
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello
Complete thread:
- Widening Cmax in EUClarc 2013-10-24 14:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Widening Cmax in EU drgunasakaran1 2013-10-24 15:43
- EMA: ABEL Helmut 2013-10-25 14:56
- EMA: ABEL Clarc 2013-10-28 10:04
Ing. Helmut Schütz