ssussu
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China,
2017-08-29 13:38
(2429 d 16:15 ago)

Posting: # 17748
Views: 2,491
 

 Extended release dosage form BE design [Design Issues]

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Dear all,
According to the FDA guidance for Mirabegron extended release tablets, there are 3 studies included. Why the study of 25mg strenth under fed condition dose not need?
Additionally, about a extended release drug，if the half life is very long e.g. 70hr，dose the AUC truncte to AUC0-72h?
Is there guidance for extended release drug specially from FDA?

Please kindly give me some advice. Thank you!
 
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