Alpha inflation [Design Issues]
Dear Ohlbe,
If the evaluation follows the same line as the EMA recommends for 3- or 4-period studies, namely forget all the data not involved in the respective comparison, the same alpha inflation as for a usual partial replicate design is expected.
See
Munoz et al.
"Consumer’s risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs"
Stat Med. 2016 May 30;35(12):1933-43.
doi: 10.1002/sim.6834. Epub 2015 Dec 28.
The method to control the TIE is coming soon ...
Meanwhile see this thread and links therein.
❝ Any idea about alpha inflation control with such a design ?
If the evaluation follows the same line as the EMA recommends for 3- or 4-period studies, namely forget all the data not involved in the respective comparison, the same alpha inflation as for a usual partial replicate design is expected.
See
Munoz et al.
"Consumer’s risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs"
Stat Med. 2016 May 30;35(12):1933-43.
doi: 10.1002/sim.6834. Epub 2015 Dec 28.
The method to control the TIE is coming soon ...

Meanwhile see this thread and links therein.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Sas proc mixed and 4 period partial replicate Cross over M.tareq 2016-05-03 11:35 [Design Issues]
- What is the purpose? Helmut 2016-05-03 12:43
- What is the purpose? M.tareq 2016-05-03 15:06
- Alpha inflation ? Ohlbe 2016-05-03 15:48
- Alpha inflationd_labes 2016-05-03 16:06
- Not with such a high CV Helmut 2016-05-03 17:49
- High CV? d_labes 2016-05-03 21:07
- Acc. to WHO PQTm Helmut 2016-05-03 21:58
- Sofosbuvir d_labes 2016-05-04 11:50
- Acc. to WHO PQTm Helmut 2016-05-03 21:58
- High CV? d_labes 2016-05-03 21:07
- What is the purpose? Helmut 2016-05-03 12:43