Warfarin Sodium 95% Upper bound criteria [RSABE / ABEL]
Dear Helmut,
I need the same guidance for Warfarin Sodium case.
If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?
There is no specific criteria given for 95% upper bound in the OGD of Warfarin Sodium.
Regards
Nirali
I need the same guidance for Warfarin Sodium case.
If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?
There is no specific criteria given for 95% upper bound in the OGD of Warfarin Sodium.
Regards
Nirali
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 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 criteriaNirali 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 criteriaNirali 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