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RegisterHigher Intrasubject CV in AUCt than Cmax [Study Performance]
Dear members,
We have conducted two pivotal studies of xxx molecule. One was conudcted under fasting state and the other one in fed state.
Intrasubject CV obtained in Fed state study for the Cmax was 31% and for AUCt was 13%. However the Intrasubject CV obatined in Fasting state study for Cmax was 24% and for AUCt was 23%.
My questions regarding to this are as follows:
We have conducted two pivotal studies of xxx molecule. One was conudcted under fasting state and the other one in fed state.
Intrasubject CV obtained in Fed state study for the Cmax was 31% and for AUCt was 13%. However the Intrasubject CV obatined in Fasting state study for Cmax was 24% and for AUCt was 23%.
My questions regarding to this are as follows:
- Is it common to obtain such kind of results.
- What is the sources of variability for AUCt in Fasting state study?
- What precautions can taken to overcome such kind of problem in future studies.
Complete thread:
- Higher Intrasubject CV in AUCt than Cmaxscorp2011 2010-11-24 08:33
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Higher Intrasubject CV in AUCt than Cmax? d_labes 2010-11-24 09:59
- Higher Intrasubject CV in AUCt than Cmax? scorp2011 2010-11-25 07:44
- Higher Intrasubject CV in AUCt than Cmax? d_labes 2010-11-24 09:59
Ing. Helmut Schütz