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Back to the forum  2018-06-22 19:01 CEST (UTC+2h)
ssussu
Junior

China,
2017-08-29 11:38

Posting: # 17748
Views: 1,022
 

 Extended release dosage form BE design [Design Issues]

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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