β = 1 – π [RSABE / ABEL]
❝ In any two way ABE study, if the 90%CI is not within the range of 80-125%, most of time the same is reflected in the T/R …
Well, the CI is constructed around the GMR.

❝ … and also the dissolution graphs.
Nope. Only if dissolution would be the rate-limiting step. Otherwise in vitro cannot (!) be predictive of in vivo. There a tons of studies with completely dissimilar dissolution profiles which passed BE easily.
❝ For NTID as per USFDAs GL below three criteria should be followed,
❝ - Upper 95% CI ≤0 (SABE)
❝ - 90% CI should be within 80-125%
❝ - UL of 90% CI for σWT/σWR should be ≤ 2.5 (ABE)
You are mixing something up. Actually:
- Upper 95% CI ≤0 (SABE)
- 90% CI should be within 80-125% (ABE)
- UL of 90% CI for σwT/σwR should be ≤ 2.5 (comparison of variabilities)
❝ As per the case mentioned in above post, the ISCV of test and ref is very low (around 6-7), T/R is near to 100 and also meeting BE criteria in ABE. So if only 95% CI in SABE does not meet criteria (0.0001) so how the reason for the difference between test and reference can be interpreted.
The FDA’s “implied BE limits” can be calculated by \(e^{\mp \log{(1.11111)}\cdot \sqrt{\log{(0.30^2+1)}}/0.1}\) which are in your case:
CV (%) BE-limits (%)
6 93.88 106.52
7 92.90 107.64
These three tests are not directly related. Fine if you pass the latter two. Bad luck if you fail the first by a small margin. How was the study powered? If you targeted a power of 80–90%, the chance of failing for a product which is BE would be 10–20%. Daily life. See John’s reply above.
Counterquestion: Did you ever succeed in convincing the FDA to accept a conventional BE study which showed a 90% CI of 79.99–125.01%?
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Science Quotes
Complete thread:
- FDA: RSABE for NTID Jay 2018-03-26 13:31 [RSABE / ABEL]
- FDA: RSABE for NTID jag009 2018-03-26 17:57
- FDA: RSABE for NTID Jay 2018-04-02 06:28
- FDA: RSABE for NTID pjs 2018-04-02 15:07
- FDA: RSABE for NTID Jay 2018-04-04 14:24
- β = 1 – πHelmut 2018-04-04 15:03
- Warfarin Sodium 95% Upper bound criteria Nirali 2019-01-30 15:38
- Upper bound in RSABE ≤0 Helmut 2019-02-02 14:15
- Upper bound in RSABE ≤0 Nirali 2019-02-12 07:10
- Upper bound in RSABE ≤0 Helmut 2019-02-02 14:15
- Warfarin Sodium 95% Upper bound criteria Nirali 2019-01-30 15:38
- β = 1 – πHelmut 2018-04-04 15:03
- FDA: RSABE for NTID Jay 2018-04-04 14:24
- FDA: RSABE for NTID pjs 2018-04-02 15:07
- FDA: RSABE for NTID Jay 2018-04-02 06:28
- FDA: RSABE for NTID jag009 2018-03-26 17:57