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scorp2011 ☆ India, 2010-11-24 09:33 (5283 d 15:07 ago) Posting: # 6208 Views: 4,713 |
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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:
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d_labes ★★★ Berlin, Germany, 2010-11-24 10:59 (5283 d 13:41 ago) @ scorp2011 Posting: # 6209 Views: 3,881 |
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Dear Scorp, I did'nt get your point. I do not see higher CV's for AUCt compared to Cmax in your numbers. — Regards, Detlew |
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scorp2011 ☆ India, 2010-11-25 08:44 (5282 d 15:56 ago) @ d_labes Posting: # 6213 Views: 3,830 |
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❝ I did'nt get your point. I do not see higher CV's for AUCt compared to Cmax in your numbers. Dear Labes, My point is that if we compare the ISCV in Fasting state and Fed state, there is 18 points diffence between ISCV for Cmax and AUC in Fed state while there is 1 point diffence between ISCV for Cmax and AUC in Fasting state study. Also, usually the variability for AUC parameter is quite low as compared to Cmax since Cmax is a single point estimate. I hope I am been able to clarify my point. Hoping to recieve an answer on this very soon. Thanks in advance |
Ing. Helmut Schütz