Bioequivalence and Bioavailability Forum • FDA's RSABE on NTIDs in R

FDA's RSABE on NTIDs in R [RSABE / ABEL]

posted by CECIF – Colombia, 2018-03-01 22:08 (2629 d 23:05 ago) – Posting: # 18491
Views: 14,790

Dear Detlew

❝ I will try my best :cool: .

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
- 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
  - 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