FDA: RSABE for NTID [RSABE / ABEL]

posted by Jay – India, 2018-04-04 14:24 (1343 d 06:46 ago) – Posting: # 18639
Views: 5,985

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

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