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RegisterBE criteria (suspension) [Regulatives / Guidelines]
Dear Pravin,
A little more info would be a good idea: Which drug, and is it a BE study for safety, efficacy or both? What can you tell about the therapeutic window? And above all: What is the purpose of your study?
At any rate, 505(b)(2)'s are new drugs and as such you do have some freedom in your approach so you do have a possiblity to approach the FDA in a pre-IND meeting and suggest whatever acceptance range you find relevant.
❝ 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?
A little more info would be a good idea: Which drug, and is it a BE study for safety, efficacy or both? What can you tell about the therapeutic window? And above all: What is the purpose of your study?
At any rate, 505(b)(2)'s are new drugs and as such you do have some freedom in your approach so you do have a possiblity to approach the FDA in a pre-IND meeting and suggest whatever acceptance range you find relevant.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- BE criteria (suspension) pravin17 2010-10-05 14:22 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE criteria (suspension)ElMaestro 2010-10-05 15:26
Ing. Helmut Schütz