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Register3 period BE studies, 3 or 6 sequence [Design Issues]
Hi all,
For a FDA 3-way BE studies (I know, it's strange), does it matter if I use 3 or 6 sequence? I plan to go with 3 sequence because I don't want to see a case where 1 sequence ends up with only 1 or 2 subjects due to dropouts whiles other sequence have more. ie: 24 subjects, 6 sequence, what if I happen to lose 4-5 subjects in sequence #4 (Hey people win a lottery sometime)
I know the old food effect study in the FDA BE guidance (long long back), the one which evaulated Test fed, Ref Fed, test Fast. I think 6 sequence was required.
Thanks
John
For a FDA 3-way BE studies (I know, it's strange), does it matter if I use 3 or 6 sequence? I plan to go with 3 sequence because I don't want to see a case where 1 sequence ends up with only 1 or 2 subjects due to dropouts whiles other sequence have more. ie: 24 subjects, 6 sequence, what if I happen to lose 4-5 subjects in sequence #4 (Hey people win a lottery sometime)
I know the old food effect study in the FDA BE guidance (long long back), the one which evaulated Test fed, Ref Fed, test Fast. I think 6 sequence was required.
Thanks
John
Complete thread:
- 3 period BE studies, 3 or 6 sequencejag009 2012-06-06 22:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 3 period BE studies, 3 or 6 sequence Helmut 2012-06-07 13:48
- 3 period BE studies, 3 or 6 sequence drgunasakaran1 2012-06-07 17:48
- 3 period BE studies, 3 or 6 sequence jag009 2012-06-07 20:02
- Lost sequence d_labes 2012-06-08 08:49
- 3 period BE studies, 3 or 6 sequence jag009 2012-06-07 20:02
Ing. Helmut Schütz