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RegisterReporting RSABE to the FDA [RSABE / ABEL]
Hi Helmut,
I think it's a "One table for everything" thing... The "Method Used" is to indicate whether RSABE or ABE was used. When I filled in my table I prepared it appropriately. Example, if method used for AUCt was RSABE then I would present the data only necessary for RSABE. If method used for Cmax was ABE then I would present the data for ABE. Only s2wr and sWR, T/R, method used and outcome need to be presented at all time.
John
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![[image]](img/uploaded/image167.png)
❝ I thought the T/R Ratio (⊂ [0.8000, 1.2500], sWR (≥ 0.294), and the upper one-sided 95% CI (≤ 0) are enough to demonstrate RSABE.
❝ Obviously they want the 90% CI as well (nice to know!) and the s²WR (to check whether we are able to take its square root?). Any ideas what they might mean by “Method Used”?
I think it's a "One table for everything" thing... The "Method Used" is to indicate whether RSABE or ABE was used. When I filled in my table I prepared it appropriately. Example, if method used for AUCt was RSABE then I would present the data only necessary for RSABE. If method used for Cmax was ABE then I would present the data for ABE. Only s2wr and sWR, T/R, method used and outcome need to be presented at all time.
John
Complete thread:
- Reporting RSABE to the FDA Helmut 2013-05-03 01:03
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reporting RSABE to the FDAjag009 2013-05-03 16:37
Ing. Helmut Schütz