Log in
RegisterBiowaiver for intravenous drug / Anticancer molecule [Design Issues]
Dear All,
As per different guidelines recommendation, that we can biowaive the parentals or intravenous injection. Can any body tell me that can we apply for the biowaiver of one of anticancer molecule by demonstrating the invitro release profile with that compare with innovator products. Is it possible to conduct the invitro bioequivalence of intravenous injection of anticancer molecule. I hope you will revert back to me.
Regards
pk
Edit: Category changed. [Helmut]
As per different guidelines recommendation, that we can biowaive the parentals or intravenous injection. Can any body tell me that can we apply for the biowaiver of one of anticancer molecule by demonstrating the invitro release profile with that compare with innovator products. Is it possible to conduct the invitro bioequivalence of intravenous injection of anticancer molecule. I hope you will revert back to me.
Regards
pk
Edit: Category changed. [Helmut]
Complete thread:
- Biowaiver for intravenous drug / Anticancer moleculekishorpatil 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