FDA's RSABE on NTIDs in R [RSABE / ABEL]
Dear Detlew
Felt like life-saving answer for me.
So I used your R code from the thread you sent me (Marvelous coding btw), on Helmut's datafile http://bebac.at/downloads/NTID.xls
And these are my results:
Now, If I understand correctly this is bioequivalent because:
1. 95% CI of RSABE criterion= -0.009828289 <0
2. Conventional ABE test: 0.9 < 0.9429483, 1.11>1.029172 (or is it also with conventional limits 0.8 and 1.25?).
3. Upper 90% CI of the ratio swT/swR: 0.6842668<=2.5
In addition to this, do I still have to demonstrate conventional bioequivalence for:
as they do here? https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin%20Sodium_Approv.pdf
In any case, many thanks.
❝ I will try my best .
Felt like life-saving answer for me.
So I used your R code from the thread you sent me (Marvelous coding btw), on Helmut's datafile http://bebac.at/downloads/NTID.xls
And these are my results:
> FDA_Narrow_CECIF(filename)
SwR ABE.Lower ABE.upper ratioDS_IC.lower ratioDS_IC.upper uppRSABE
1 0.1243928 0.9429483 1.029172 0.2932383 0.6842668 -0.009828289
Now, If I understand correctly this is bioequivalent because:
1. 95% CI of RSABE criterion= -0.009828289 <0
2. Conventional ABE test: 0.9 < 0.9429483, 1.11>1.029172 (or is it also with conventional limits 0.8 and 1.25?).
3. Upper 90% CI of the ratio swT/swR: 0.6842668<=2.5
In addition to this, do I still have to demonstrate conventional bioequivalence for:
❝ 1. Period 1 vs period 2 (regular bioequivalence study)
❝ 2. Period 3 vs period 4 (replicated study)
❝ 3. Pooled analysis (Average periods 1 and 3 vs average period 2 and 4)
as they do here? https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin%20Sodium_Approv.pdf
In any case, many thanks.
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 NTIDs Helmut 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 NTIDs Helmut 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 RCECIF 2018-03-01 21:08
- FDA's RSABE on NTIDs in R Helmut 2018-03-01 23:39
- FDA's RSABE on NTIDs in RCECIF 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