FDA: RSABE for NTID [RSABE / ABEL]
Thanks, John for the reply...
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 we generally proceed with scaled approach when the ISCV is high (more than 30%) and would not meet BE criteria with ABE approach.
Please let me know your views on the same.
Regards,
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 we generally proceed with scaled approach when the ISCV is high (more than 30%) and would not meet BE criteria with ABE approach.
Please let me know your views on the same.
Regards,
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 NTIDJay 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 NTIDJay 2018-04-02 06:28
- FDA: RSABE for NTID jag009 2018-03-26 17:57