ssussu ☆ China, 2017-08-29 13:38 (2425 d 23:27 ago) Posting: # 17748 Views: 2,487 |
|
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! |