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RegisterBiowaiver for Oral solutions [Dissolution / BCS / IVIVC]
Dear All
Please accept my apology in advance for asking a simple question, but I am not an expert in this field at all.
If I am developing a new IR solution formulation for a drug which is BCS Class 1 or 3, and which has previously only been marketed as a IR solid oral dosage form, is it acceptable to apply for a biowaiver? All the regulatory documents I have looked at only talk about soild oral dosage forms.
I look forward to hearing your replies.
Sincerely
Dr H. Mulla
TEDIC
Edit: Category changed. [Helmut]
Please accept my apology in advance for asking a simple question, but I am not an expert in this field at all.
If I am developing a new IR solution formulation for a drug which is BCS Class 1 or 3, and which has previously only been marketed as a IR solid oral dosage form, is it acceptable to apply for a biowaiver? All the regulatory documents I have looked at only talk about soild oral dosage forms.
I look forward to hearing your replies.
Sincerely
Dr H. Mulla
TEDIC
Edit: Category changed. [Helmut]
Complete thread:
- Biowaiver for Oral solutionsHussain Mulla 2009-05-12 18:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz