BE criteria (suspension) [Regulatives / Guidelines]
Dear friends,
I am preparing protocol of BE study for 505 2(b) submission
In that suspension is compared against capsule.
My Qstion is What will be the Bioequivalence criteria for this study?
Pravin Borde
Edit: Subject line changed. [Helmut]
I am preparing protocol of BE study for 505 2(b) submission
In that suspension is compared against capsule.
My Qstion is What will be the Bioequivalence criteria for this study?
Pravin Borde
Edit: Subject line changed. [Helmut]
Complete thread:
- BE criteria (suspension)pravin17 2010-10-05 14:22 [Regulatives / Guidelines]
- BE criteria (suspension) ElMaestro 2010-10-05 15:26
