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RegisterBiowaiver for Emusion Dosage Form [Design Issues]
Dear all,
Good morning.
One of our sponsor wants to conduct Bioequivalence study for an Emulsion formulation for intravenous route. Sponsor plans to market the drug as generic version of Innovator in South Africa. But, he enquired whether we can go for biowaiver instead of BE study for Emulsion formulation.
Suraj.
Good morning.
One of our sponsor wants to conduct Bioequivalence study for an Emulsion formulation for intravenous route. Sponsor plans to market the drug as generic version of Innovator in South Africa. But, he enquired whether we can go for biowaiver instead of BE study for Emulsion formulation.
Suraj.
Complete thread:
- Biowaiver for Emusion Dosage Formsurajpatel 2021-05-11 10:27 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for Emusion Dosage Form drgunasakaran1 2021-05-12 07:52
Ing. Helmut Schütz