Validation of FDA's RSABE on NTIDs [RSABE / ABEL]
❝ But from the formula in the guidance (page 4, line 5) with Alpha=0.1, I guess the guidance is right, it calulates 90% CI of Swt/Swr, but not 95% CI.
❝ Need your clarification? or FDA is wrong?
The FDA is never wrong. But so am I.

❝ ❝ Personally I would prefer […] to run a mixed effects model with restricted maximum likelihood…
❝ ❝ I got: CVwR 15.86% and CVwT 5.73%. Interesting.
❝
❝ I guess your result of 15.86% and 5.73% are obtain from the sheet of "Final Variance Parameters" from ABE results using PHX WNL.
Correct.
❝ Here the CVwr and CVwt are different from those calculated from Swr and Swt.
❝ I prefer the result calculated from Swr and Swt.
❝ What's your opinion?
For my preferences see above. If you have to follow the guidance that’s not an option.
BTW, if you have Phoenix WinNonlin why bother fiddling around in Excel? I have some doubts whether an agency will accept that. At least the EMA wouldn’t. Quoting the Q&A document:
3.3. Alternative computer programs
[…] Results obtained by alternative, validated statistical programs are also acceptable except spreadsheets because outputs of spreadsheets are not suitable for secondary assessment.
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Helmut Schütz
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Science Quotes
Complete thread:
- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-22 18:01 [RSABE / ABEL]
- Validation of FDA's RSABE on NTIDs Helmut 2017-08-22 20:25
- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-23 05:30
- Validation of FDA's RSABE on NTIDsHelmut 2017-08-23 15:00
- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-30 14:33
- Validation of FDA's RSABE on NTIDs Helmut 2017-08-30 15:04
- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-30 14:33
- Validation of FDA's RSABE on NTIDsHelmut 2017-08-23 15:00
- Clarification needed: Validation of FDA's RSABE on NTIDs CECIF 2018-02-19 22:20
- FDA's RSABE on NTIDs in R d_labes 2018-02-20 14:10
- FDA's RSABE on NTIDs in R CECIF 2018-03-01 21:08
- FDA's RSABE on NTIDs in R Helmut 2018-03-01 23:39
- FDA's RSABE on NTIDs in R CECIF 2018-03-01 21:08
- FDA's RSABE on NTIDs in R d_labes 2018-02-20 14:10
- Validation of FDA's RSABE on NTIDs yicaoting 2017-08-23 05:30
- Validation of FDA's RSABE on NTIDs Helmut 2017-08-22 20:25