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RegisterBiowaiver [Dissolution / BCS / IVIVC]
Dear All,
It would be greatly appriciable
if some one provide your valuable suggestions for the below query
If a formulation contains dose propotionality only for active ingreadientin various stregth; the exepients are qualitatively same and quantitatively there is a marginal difference in some exepients and the fill wieght is identical for all, in such case can we get biowaiver for the lower stregths.
Edit: Category changed. Please see also this post. [HS]
It would be greatly appriciable
if some one provide your valuable suggestions for the below queryIf a formulation contains dose propotionality only for active ingreadientin various stregth; the exepients are qualitatively same and quantitatively there is a marginal difference in some exepients and the fill wieght is identical for all, in such case can we get biowaiver for the lower stregths.
Edit: Category changed. Please see also this post. [HS]
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Alhas
Alhas
Complete thread:
- BiowaiverBEAZ 2008-06-13 12:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver John Gray 2008-06-19 06:36
Ing. Helmut Schütz