Risking Refuse-to-Receive [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-03-28 21:35 (1308 d 07:01 ago) – Posting: # 18608
Views: 2,403

Hi Helmut!

» In my experience you will get the highest CV in the first partial AUC of the fasting study. I never saw a high CV of Cmax… A CVwR >30% of AUC0-3 is extremely unlikely.
» @John: Other experiences?

Yes the culprit is the first partial AUC. However, if the coating on your delayed release bead is acting funny then it's possible for you to see high CV on the 1st and 2nd partial AUCs...


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