FDA: RSABE for NTID [RSABE / ABEL]

posted by Jay – India, 2018-03-26 13:31  – Posting: # 18595
Views: 2,849

(edited by Jay on 2018-03-26 13:50)

Dear all,

In one of the full replicate study of NTID the results are as per below,

Parameters   Swr    95%CI
LnCmax       0.04   0.0001
LnAUC0-t     0.07   -0.003
LnAUC0-inf   0.07   -0.004


The ABE results are as below,

Parameters   T/R    90%CI-L    90%CI-U
LnCmax       97     95         99
LnAUC0-t     99     97         101
LnAUC0-inf   99     97         101


The point estimate is near to 100 and ABE is also within 80% to 125%.

But in SABE, the Cmax criteria is more than 0 i.e. 0.0001 which leads to bioinequivalence.

So can it be scientifically justified the 95%CI of Cmax value as its very borderline to 0 and T/R shows less difference between test and reference.

Thanks

-Jay


Edit: Category and subject line changed; see also this post #1 and #2. [Helmut]

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