pguelen
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2009-06-16 18:02
(6222 d 15:32 ago)

Posting: # 3861
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 potassium modified release formulations [Regulatives / Guidelines]

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I was wondering if BE/BA studies are required in Europe for the registration of a generic potassium modified release formulatiion, or that a biowaiver would do. I could not find any information on the web, except from US FDA guidelines.

Pieter, the Netherlands

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Edit: Category changed. [Helmut]
 
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