BEAZ
★    

India,
2008-06-13 12:56

Posting: # 1943
Views: 3,720
 

 Biowaiver [Dissolution / BCS / IVIVC]

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
John Gray
●    

2008-06-19 06:36
(edited by Ohlbe on 2008-06-19 09:38)

@ BEAZ
Posting: # 1949
Views: 3,063
 

 Biowaiver

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]
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