Posting: # 1943
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]
(edited by Ohlbe on 2008-06-19 09:38)
Posting: # 1949
You get a biowaiver if the ratio of the excipeints to the total weight of dosage forms are within the limits as per supac-IR or supac-MR (if urs is a extended release) upto level-1 and level-2.
Edit: Full quote removed. Please see this post! [Ohlbe]