Two tests and one reference [General Statistics]
Hi libaiyi,
If this is a pivotal study (say you want to demonstrate BE of a capsule (T1) and a tablet (T2) to R which is either a tablet or a capsule) IMHO, you should employ Bonferroni’s 95% which preserves the familywise error rate at 1-(1-0.05/2)2=4.9375%. Reason: When both products are approved, based on ABE a patient my switch from R to T1 or from R to T2.
Slightly off topic: Another story would be one test and two references of different regions. If we ignore tourists, we have two different populations of patients. Then we don’t have to adjust α and go with the 90% CI.
That’s a matter of taste. Williams’ designs are variance-balanced even for carryover (which is not part of the model). Hence, some people (see there) prefer them over Latin Squares. BTW, the EMA’s GL states the six-sequence Williams’ design for the story mentioned above.
More important than the design is the evaluation (see this post).
❝ […] the goal is to prove the equivalence of any two of them (T1 and R or T2 and R). Will the CI still determined as 95% or 90%?
If this is a pivotal study (say you want to demonstrate BE of a capsule (T1) and a tablet (T2) to R which is either a tablet or a capsule) IMHO, you should employ Bonferroni’s 95% which preserves the familywise error rate at 1-(1-0.05/2)2=4.9375%. Reason: When both products are approved, based on ABE a patient my switch from R to T1 or from R to T2.
Slightly off topic: Another story would be one test and two references of different regions. If we ignore tourists, we have two different populations of patients. Then we don’t have to adjust α and go with the 90% CI.
❝ I also want to know how to select the suitable design between latin squares and William design when there exists three treatment, R T1 T2.
That’s a matter of taste. Williams’ designs are variance-balanced even for carryover (which is not part of the model). Hence, some people (see there) prefer them over Latin Squares. BTW, the EMA’s GL states the six-sequence Williams’ design for the story mentioned above.
More important than the design is the evaluation (see this post).
—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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Complete thread:
- Decision of confidence interval of three period BE study libaiyi 2018-06-26 12:00 [General Statistics]
- Two tests and one referenceHelmut 2018-06-26 13:13
- Two tests and one reference Brus 2020-08-31 09:58
- Two tests and one reference ElMaestro 2020-08-31 10:23
- Two regions: No α adjustment Helmut 2020-08-31 10:26
- Two regions: No α adjustment Brus 2020-08-31 11:09
- Two regions: different populations Helmut 2020-08-31 11:26
- Two regions: No α adjustment Brus 2020-08-31 11:09
- Two tests and one reference Brus 2020-08-31 09:58
- Decision of confidence interval of three period BE study ElMaestro 2018-06-26 22:20
- Any of two tests and one reference Helmut 2018-06-27 00:33
- Any of two tests and one reference libaiyi 2018-06-27 08:25
- Hey wait a moment.... ElMaestro 2018-06-27 08:29
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Pilot or pivotal ? Ohlbe 2018-06-27 12:14
- Pilot or pivotal ? ElMaestro 2018-06-27 13:01
- Pilot or pivotal ? Ohlbe 2018-06-27 14:13
- Pilot or pivotal ? ElMaestro 2018-06-27 14:48
- Pilot or pivotal ? Ohlbe 2018-06-27 15:43
- Pilot or pivotal ? ElMaestro 2018-06-27 22:13
- Pilot or pivotal ? Ohlbe 2018-06-27 15:43
- Pilot or pivotal ? ElMaestro 2018-06-27 14:48
- Pilot or pivotal ? Ohlbe 2018-06-27 14:13
- Pilot or pivotal ? jag009 2018-06-29 20:53
- Pilot or pivotal ? ElMaestro 2018-06-29 22:11
- Pilot or pivotal ? jag009 2018-07-03 17:38
- Pilot or pivotal ? ElMaestro 2018-06-29 22:11
- Pilot or pivotal ? ElMaestro 2018-06-27 13:01
- Hey, hey wait another moment.... d_labes 2018-06-28 19:48
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Old belives die hard d_labes 2018-07-04 13:28
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Pilot or pivotal ? Ohlbe 2018-06-27 12:14
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Any of two tests and one reference Helmut 2018-06-27 00:33
- Two tests and one referenceHelmut 2018-06-26 13:13