FDA: RSABE for NTID [RSABE / ABEL]
Dear pjs,
Thanks for the reply.
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 and also the dissolution graphs.
For highly variable product, if the 95% CI is not ≤0, the T/R ratio would be very high and beyond the range of 80 to 125%.
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)
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.
Thanks in advance.
-Jay
Thanks for the reply.
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 and also the dissolution graphs.
For highly variable product, if the 95% CI is not ≤0, the T/R ratio would be very high and beyond the range of 80 to 125%.
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)
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.
Thanks in advance.
-Jay
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 NTIDJay 2018-04-04 14:24
- β = 1 – π Helmut 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 – π Helmut 2018-04-04 15:03
- FDA: RSABE for NTIDJay 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