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Hi,
we are in a same situation, like the predose concentration is above 5% of Cmax and yet less than LOQ, (Predose concentrations are observed both in period 1 and period 2).
as the PK analysis is at other location, do we need to report the predose concentrations (even though less than LOQ) which are above 5% of Cmax?
since as per our procedures, all the concentrations below the LOQ will be replaced by "0" in the data submitted for PK analysis.
if i do that, the PK personnel/Statistician does not know about the predose concentrations above 5% of Cmax.
please advice to handle the situation.
Regards,
we are in a same situation, like the predose concentration is above 5% of Cmax and yet less than LOQ, (Predose concentrations are observed both in period 1 and period 2).
as the PK analysis is at other location, do we need to report the predose concentrations (even though less than LOQ) which are above 5% of Cmax?
since as per our procedures, all the concentrations below the LOQ will be replaced by "0" in the data submitted for PK analysis.
if i do that, the PK personnel/Statistician does not know about the predose concentrations above 5% of Cmax.
please advice to handle the situation.
Regards,
Complete thread:
- Concentration in the predose sample Shireen Janbek 2008-09-10 10:17
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- Concentration in the predose sample ElMaestro 2008-09-10 10:44
- Concentration in the predose sample Shireen Janbek 2008-09-11 06:36
- Concentration in the predose sample Ohlbe 2008-09-10 10:49
- Concentration in the predose sampleDebbie 2009-06-29 17:35
- Concentration in the predose sample Ohlbe 2009-07-05 22:24
- Concentration in the predose sampleDebbie 2009-06-29 17:35
- Concentration in the predose sample martin 2008-09-10 13:25
- Paper concerning adjustment for baseline levels martin 2008-09-29 13:18
- Concentration in the predose sample ElMaestro 2008-09-10 10:44
Ing. Helmut Schütz