Biowaiver [Dissolution / BCS / IVIVC]

posted by BEAZ – India, 2008-06-13 12:56  – Posting: # 1943
Views: 3,721

Dear All,

It would be greatly appriciable :-P 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]

Alhas

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