BEAZ ★ India, 2008-06-13 14:56 (5768 d 00:51 ago) Posting: # 1943 Views: 5,078 |
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Dear All, 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] — Alhas |
John Gray ● 2008-06-19 08:36 (5762 d 07:11 ago) (edited by Ohlbe on 2008-06-19 09:38) @ BEAZ Posting: # 1949 Views: 4,099 |
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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. -- Edit: Full quote removed. Please see this post! [Ohlbe] |