Bioequivalence and Bioavailability Forum • Biowaiver

BEAZ
★

India,
2008-06-13 14:56
(6577 d 09:42 ago)

Posting: # 1943
Views: 7,388

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 08:36 (6571 d 16:03 ago) (edited on 2008-06-19 09:38) @ BEAZ Posting: # 1949 Views: 5,839	Biowaiver Post reply
	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]