BEAZ
★    

India,
2008-06-13 14:56
(6232 d 04:00 ago)

Posting: # 1943
Views: 6,275
 

 Biowaiver [Dissolution / BCS / IVIVC]

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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 08:36
(6226 d 10:21 ago)

(edited on 2008-06-19 09:38)
@ BEAZ
Posting: # 1949
Views: 4,990
 

 Biowaiver

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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.

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Edit: Full quote removed. Please see this post! [Ohlbe]
 
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