Different doses or strenghts? [General Sta­tis­tics]

posted by kumarnaidu – Mumbai, India, 2013-11-21 15:00 (3672 d 02:01 ago) – Posting: # 11935
Views: 7,658

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.:confused:

Kumar Naidu

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