Log in
RegisterAdd-on study data combining procedure [Two-Stage / GS Designs]
Dear Mr Msmnainar,
As per Canadian BE guideline, if the study is run with the appropriate size and the standards are not met, the sponsor may add more subjects (a minimum of 12). The same protocol should be used (i.e., same formulations, same lots, same blood sampling times, a minimum number of 12 subjects, etc.). The choice to use this strategy, as with all designs, should be declared and justified a priori.
The level of confidence should be adjusted using the Bonferroni procedure.
The t-value should be that for p=.025 instead of .05.
As per Canadian BE guideline, if the study is run with the appropriate size and the standards are not met, the sponsor may add more subjects (a minimum of 12). The same protocol should be used (i.e., same formulations, same lots, same blood sampling times, a minimum number of 12 subjects, etc.). The choice to use this strategy, as with all designs, should be declared and justified a priori.
The level of confidence should be adjusted using the Bonferroni procedure.
The t-value should be that for p=.025 instead of .05.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Add-on study data combining procedure msmnainar 2013-02-14 08:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Add-on study data combining proceduredrgunasakaran1 2013-02-14 09:54
- Add-on study data combining procedure msmnainar 2013-02-14 10:39
- Ref’s for Methods C/D Helmut 2013-02-14 13:32
- Ref’s for Methods C/D msmnainar 2013-02-14 13:40
- Ref’s for Methods C/D Helmut 2013-02-14 13:32
- No more add-ons for submissions in Canada Helmut 2013-02-14 13:22
- Add-on study data combining procedure msmnainar 2013-02-14 10:39
- Add-on study data combining proceduredrgunasakaran1 2013-02-14 09:54
Ing. Helmut Schütz