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Hi Helmut!
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...
John
❝ 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...
John
Complete thread:
- FDA-Subject by formulation interaction (Switchability) sudy 2018-03-28 07:09 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Risking Refuse-to-Receive Helmut 2018-03-28 11:25
- Risking Refuse-to-Receive sudy 2018-03-28 12:13
- Risking Refuse-to-Receivejag009 2018-03-28 21:35
- FDA-Subject by formulation interaction (Switchability) jag009 2018-03-28 21:33
- Risking Refuse-to-Receive Helmut 2018-03-28 11:25
Ing. Helmut Schütz