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RegisterComparative pharmacokinetics [General Statistics]
Dear Santosh,
if you do not know anything about the way "comparability" should be demonstrated (what is stated in the protocol?) you may define the AUC0.tlast as the primary endpoint and AUC0-Inf, MRT, IR, ... as secondary ones. However, meaningful parameters depend on the application route. Then you calculate the points estimates and 95% CI for each parameter, and the ratio and the corresponding 90% CI for the ratio. If you do not provide any CI for the ratio, it is hard to evaluate whether a difference really exists.
Regards,
JPL
if you do not know anything about the way "comparability" should be demonstrated (what is stated in the protocol?) you may define the AUC0.tlast as the primary endpoint and AUC0-Inf, MRT, IR, ... as secondary ones. However, meaningful parameters depend on the application route. Then you calculate the points estimates and 95% CI for each parameter, and the ratio and the corresponding 90% CI for the ratio. If you do not provide any CI for the ratio, it is hard to evaluate whether a difference really exists.
Regards,
JPL
Complete thread:
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- Comparative pharmacokinetics ElMaestro 2009-01-15 16:15
- Comparative pharmacokinetics santosh.awale 2009-01-15 10:24
- Comparative pharmacokinetics Helmut 2009-01-13 21:28
- Comparative pharmacokinetics ElMaestro 2009-01-13 14:14
- Comparative pharmacokinetics Helmut 2009-01-11 12:59
- Comparative pharmacokinetics santosh.awale 2009-01-09 06:01
Ing. Helmut Schütz