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RegisterDifferent doses or strenghts? [General Statistics]
Hi all,
I got one protocol for review. In that they have given some different design which I want to share with you.
They are having two cohorts. In cohort 1 15 patients will receive T (5 subjects in each dose category) and 15 will receive R
T1, T2 and T3 are different doses. In Cohort 2 - Subject received T in cohort 1 will receive R and Subject received R will receive T (T1 or T2 or T3 based on some set criteria )
Cohort 1 (n = 15)
T1 (n1 = 5)
T2 (n2 = 5)
T3 (n3 = 5)
R (n = 15)
Cohort 2 (n = 15)
R(n = 15)
T1 or T2 or T3 (n = 15)
Bioequivalence will be evaluated in cohort 2. And cohort one will be used for dose identification. According to me we need to use parallel design here for analysis in cohort 2 but what about period and sequence effect.
I got one protocol for review. In that they have given some different design which I want to share with you.
They are having two cohorts. In cohort 1 15 patients will receive T (5 subjects in each dose category) and 15 will receive R
T1, T2 and T3 are different doses. In Cohort 2 - Subject received T in cohort 1 will receive R and Subject received R will receive T (T1 or T2 or T3 based on some set criteria )
Cohort 1 (n = 15)
T1 (n1 = 5)
T2 (n2 = 5)
T3 (n3 = 5)
R (n = 15)
Cohort 2 (n = 15)
R(n = 15)
T1 or T2 or T3 (n = 15)
Bioequivalence will be evaluated in cohort 2. And cohort one will be used for dose identification. According to me we need to use parallel design here for analysis in cohort 2 but what about period and sequence effect.
—
Kumar Naidu
Kumar Naidu
Complete thread:
- Dose based on m² VK 2013-07-17 10:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dose based on m² Dr_Dan 2013-07-17 11:09
- Dose based on m² VK 2013-07-17 16:17
- Different doses or strenghts? Helmut 2013-07-17 12:18
- Different doses or strenghts? VK 2013-07-17 16:31
- No problem with same strength but different doses Helmut 2013-07-17 23:17
- Different doses or strenghts? luvblooms 2013-07-18 06:42
- Different doses or strenghts? VK 2013-07-18 15:28
- Different doses or strenghts?kumarnaidu 2013-11-21 14:00
- Different doses or strenghts? Dr_Dan 2013-11-21 15:23
- Different doses or strenghts? kumarnaidu 2013-11-22 05:34
- Different doses or strenghts? Dr_Dan 2013-11-21 15:23
- Different doses or strenghts?kumarnaidu 2013-11-21 14:00
- Different doses or strenghts? VK 2013-07-18 15:28
- Different doses or strenghts? VK 2013-07-17 16:31
- Dose based on m² Dr_Dan 2013-07-17 11:09
Ing. Helmut Schütz