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Back to the forum  Query: 2017-11-23 19:29 CET (UTC+1h)
 

Extended release dosage form BE design [Design Issues]

posted by ssussu - China, 2017-08-29 11:38  - Posting: # 17748
Views: 476

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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