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vivekanand ☆ India, 2015-01-19 06:54 (3765 d 02:57 ago) Posting: # 14300 Views: 5,564 |
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Dear All Hi, I have a question "In a BA/BE study if two periods were there, where in one period dosing started at 08:00 hr for subjects and in second period if dosing started at 09:00 hr for subjects". Is this having any impact. Eventhough protocol of the study does not specify uniform dosing time to be followed in both periods.However protocol specifyies that events after dosing like smaple collection and others shall be vary based on dosing time of study period. Regards G.Balavivekanand Edit: Category changed. [Helmut] |
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ElMaestro ★★★ Denmark, 2015-01-19 12:41 (3764 d 21:10 ago) @ vivekanand Posting: # 14302 Views: 4,245 |
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Hi vivekanand, it shouldn't be too much of a deal, but at least in theory it might affect your result; the dosing slot in period 2 will, if I get you right, be a between subject issue and from that perspective it will not be affecting the intra-subject variability. But if you the phlebotomist or someone/something in slot 2 is causing the variability to differ from slot 1 then it will impact the apparent within-subject variability and thus your CI. I think it is up to you to judge any impact. Only people who are intimately familiar with how things work in your clinic can judge it, I think. it is fairly common for logistical reasons to dose some people at 7am, others at 8am etc. — Pass or fail! ElMaestro |
Ing. Helmut Schütz