Hussain Mulla
☆    

2009-05-12 20:34
(5461 d 14:23 ago)

Posting: # 3678
Views: 3,137
 

 Biowaiver for Oral solutions [Dissolution / BCS / IVIVC]

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Dear All

Please accept my apology in advance for asking a simple question, but I am not an expert in this field at all.

If I am developing a new IR solution formulation for a drug which is BCS Class 1 or 3, and which has previously only been marketed as a IR solid oral dosage form, is it acceptable to apply for a biowaiver? All the regulatory documents I have looked at only talk about soild oral dosage forms.

I look forward to hearing your replies.

Sincerely

Dr H. Mulla
TEDIC

Edit: Category changed. [Helmut]
 
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