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RegisterBE study of Single Vs Multiple [Design Issues]
Hi Raghu,
remember bioequivalence study is performed in same strength, hence you dose (3 x 6= 18 mg) three tablets of reference at time which is equivalent to the test product strenth i.e. 18 mg.
if you administered reference product Thrice In a Day then each of Cmax will be at different time then how will you show the equivalence with test Cmax.
regards.
Santosh A.
remember bioequivalence study is performed in same strength, hence you dose (3 x 6= 18 mg) three tablets of reference at time which is equivalent to the test product strenth i.e. 18 mg.
if you administered reference product Thrice In a Day then each of Cmax will be at different time then how will you show the equivalence with test Cmax.
regards.
Santosh A.
Complete thread:
- BE study of Single Vs Multiple raghu 2008-12-24 10:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study of Single Vs Multiplesantosh.awale 2008-12-24 12:55
- Conceptual flaw? Helmut 2008-12-24 13:05
- Comparative BA (MR vs. IR) Helmut 2008-12-24 13:00
- BE study of Single Vs Multiplesantosh.awale 2008-12-24 12:55
Ing. Helmut Schütz