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RegisterExtended 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!
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!
Complete thread:
- Extended release dosage form BE designssussu 2017-08-29 11:38
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Ing. Helmut Schütz