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RegisterBiowaiver for intravenous formulation?! [Design Issues]
Hi Kishor!
I'm afraid I don't understand your question.
As you said, generally no study is required for iv formulations.
Next you talked about in vitro release - of a solution?!
If you have an immediate relase oral formulation, you might get a biowaiver if the drug belongs to BCS I (and maybe class III). See the respective guidelines for requirements.
The BCS-based biowaiver concept does not distinguish between therapeutic classes of drugs. Whether you have an anticancer drug or not is irrelevant. In some regulations NTIDs prohibt biowaivers.
I'm afraid I don't understand your question.
As you said, generally no study is required for iv formulations.
Next you talked about in vitro release - of a solution?!
If you have an immediate relase oral formulation, you might get a biowaiver if the drug belongs to BCS I (and maybe class III). See the respective guidelines for requirements.
The BCS-based biowaiver concept does not distinguish between therapeutic classes of drugs. Whether you have an anticancer drug or not is irrelevant. In some regulations NTIDs prohibt biowaivers.
—
Regards, Jaime
Regards, Jaime
Complete thread:
- Biowaiver for intravenous drug / Anticancer molecule kishorpatil 2011-02-09 11:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for intravenous formulation?!Jaime_R 2011-02-10 18:10
Ing. Helmut Schütz