Power in the pivotal study (EU) [Power / Sample Size]
Dear All,
Greetings!!!
We have conducted a pivotal study for Europe with 48 subjects considering ~80% power, ISCV: 23%. The study was bioequivalent and 90% CI is within 80-125 for both Cmax & AUCt.
Power of Cmax and AUCt are 92% & 66% respectively. Kindly guide us how to justify the power less than 80% to HA.
Thanks
Valiveti
Greetings!!!
We have conducted a pivotal study for Europe with 48 subjects considering ~80% power, ISCV: 23%. The study was bioequivalent and 90% CI is within 80-125 for both Cmax & AUCt.
Power of Cmax and AUCt are 92% & 66% respectively. Kindly guide us how to justify the power less than 80% to HA.
Thanks
Valiveti
Complete thread:
- Power in the pivotal study (EU)valivetiananth 2018-05-31 13:49 [Power / Sample Size]
- Stop estimating post hoc power! Helmut 2018-05-31 14:45
- Stop estimating post hoc power! ElMaestro 2018-05-31 15:43
- Confession Helmut 2018-05-31 17:16
- Confession ElMaestro 2018-05-31 21:47
- Confession Helmut 2018-06-01 00:01
- Confession ElMaestro 2018-06-01 08:31
- Silly-O-Meter: Syntax Helmut 2018-06-01 13:42
- Silly-O-Meter: Syntax ElMaestro 2018-06-01 15:17
- Silly-O-Meter: Syntax Helmut 2018-06-01 13:42
- Confession ElMaestro 2018-06-01 08:31
- Confession Helmut 2018-06-01 00:01
- Confession ElMaestro 2018-05-31 21:47
- Confession Helmut 2018-05-31 17:16
- Stop estimating post hoc power! valivetiananth 2018-06-02 08:52
- Eligible subjects? Helmut 2018-06-02 13:02
- Don’t we deserve an answer? Helmut 2018-06-09 15:13
- Stop estimating post hoc power! ElMaestro 2018-05-31 15:43
- Stop estimating post hoc power! Helmut 2018-05-31 14:45