FDA: RSABE for NTID [RSABE / ABEL]

posted by pjs – India, 2018-04-02 15:07 (1345 d 21:30 ago) – Posting: # 18633
Views: 6,154

(edited by pjs on 2018-04-02 15:17)

Dear Jay,

» I would like to understand that how come the study passing in ABE within 80% to 125%, low T/R and low ISCV would not meet the BE criteria of scaled average bioequivalence.

As per the Swr data shared scaled BE limits would be 95.87-104.30%. Now as per the ABE data you shared lower limit is mentioned to be 95%.

Now please note that variability in ABE and SABE would be different as there will be different models for the estimation. Also for SABE only subjects who had completed all four Periods would be included and in ABE any subject with atleast one reference and one test product would be included.

You may refer the lower limit for the ilat output in SABE approach which would be outside 95.87%. This could be reason behind the upper bound value marginally more than 0. Just one quick question in the outputs for upper bound, value to be rounded off till which decimal? If you consider three decimals study is passing and with four decimals same is failing.

Also with variability as low as 4%, you also need to check test product variability to comply with variability comparison criteria.

Just to check with forum members is there any method for outlier detection in such full replicate studies? In one of the earlier posts there was discussion for use of method proposed by Lazlo for the same. Any further update for the acceptability of this approach.

Can you pls confirm how many subjects were included in the study and how sample size was defined.

Regards
Pjs

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