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RegisterIR versus MR [Design Issues]
Dear All,
I intend to perform a bioequivalence study between a immediate release formulation (IR) and a modified release formulation (MR). The study will design like that: single dose of MR formulation at time 0 (t=0h) and multiple dose of IR formulation (at time = 0h and 12h). The samples will be colleted considering 3-5 times the half-life of the drug. However, the objective would be to obtain the same bioavailability of the formulations until 24 h.
Considering the pharmacotherapy the IR fomulation is given two times per day (12/12h) and the MR formulation is given once per day (24/24h).
Your insight on this matter would be appreciated.
Daniel Rossi de Campos
Brazil
I intend to perform a bioequivalence study between a immediate release formulation (IR) and a modified release formulation (MR). The study will design like that: single dose of MR formulation at time 0 (t=0h) and multiple dose of IR formulation (at time = 0h and 12h). The samples will be colleted considering 3-5 times the half-life of the drug. However, the objective would be to obtain the same bioavailability of the formulations until 24 h.
Considering the pharmacotherapy the IR fomulation is given two times per day (12/12h) and the MR formulation is given once per day (24/24h).
Your insight on this matter would be appreciated.
Daniel Rossi de Campos
Brazil
Complete thread:
- IR versus MRdrcampos 2007-03-27 15:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IR versus MR gagandeep 2007-03-29 10:58
- IR versus MR hirenpharm 2007-04-01 14:33
- IR versus MR (not BE!) Helmut 2007-04-01 23:18
- IR versus MR gagandeep 2007-04-05 17:56
- IR versus MR gagandeep 2007-03-29 10:58
Ing. Helmut Schütz