2008-06-13 12:56

Posting: # 1943
Views: 3,882

 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]

John Gray

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

Posting: # 1949
Views: 3,187


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]
 Admin contact
20,343 posts in 4,272 threads, 1,401 registered users;
online 12 (1 registered, 11 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 22:15 CET

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz