sureshcology
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2007-11-16 14:18
(6801 d 12:09 ago)

Posting: # 1302
Views: 2,153
 

 BA/BE for two different formulations [Regulatives / Guidelines]

Dear All

As per US FDA Sec 320.23 (b) pharmaceutical alternatives can be compared was given but I wonder how two different formulations will be compared when given through different routes
To be more clear.............
A drug is available in i.v (intravenous form) and a company wanna go for tablet formulation. Since the drug is already existing in the market can we call this new tablet formulation as generic product, if so how shall we do the BA/BE between them for submission of the ANDA (for tablet formulation).

Regards

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Edit: Category changed. [HS]
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