Bioequivalence and Bioavailability Forum • Reporting RSABE to the FDA

Helmut
★★★

Vienna, Austria,
2013-05-03 03:03
(4394 d 14:35 ago)

Posting: # 10530
Views: 5,068

Reporting RSABE to the FDA [RSABE / ABEL]

Dear all,

interesting form:

[image]

I thought that the T/R Ratio (⊂ [0.8000, 1.2500], s_WR (≥ 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 s²_WR (to check whether we are able to take its square root?). Any ideas what they might mean by “Method Used”?

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jag009
★★★

NJ,
2013-05-03 18:37
(4393 d 23:01 ago)

@ Helmut
Posting: # 10536
Views: 3,853

Reporting RSABE to the FDA

Post reply

Hi Helmut,

❝

[image]

❝ I thought the T/R Ratio (⊂ [0.8000, 1.2500], s_WR (≥ 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 s²_WR (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