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

posted by CECIF – Colombia, 2018-03-01 22:08 (2233 d 16:41 ago) – Posting: # 18491
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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.

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