FDA: RSABE for NTID [RSABE / ABEL]
Dear all,
In one of the full replicate study of NTID the results are as per below,
The ABE results are as below,
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]
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]
Complete thread:
- FDA: RSABE for NTIDJay 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 – 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 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