Category now obsolete? EMEA on non-parametrics [Nonparametrics]
Good point, DLabes.
First: "In studies to determine bioequivalence after a single dose, AUCt, AUCoo, Cmax and tmax should be determined."
And then later:
"The assessment of bioequivalence is based upon 90% confidence intervals for the ratio of the population geometric means (test/reference) for the parameters under consideration."
One could get the impression that the pharmacokinetolophystic subgroup is requesting a parametric analysis of tmax including 90% CI's and the works, had it not been for the final punch:
"In studies to determine bioequivalence after a single dose, the parameters to be analysed are AUCt and Cmax."
...so why do they want tmax at all?
EM.
First: "In studies to determine bioequivalence after a single dose, AUCt, AUCoo, Cmax and tmax should be determined."
And then later:
"The assessment of bioequivalence is based upon 90% confidence intervals for the ratio of the population geometric means (test/reference) for the parameters under consideration."
One could get the impression that the pharmacokinetolophystic subgroup is requesting a parametric analysis of tmax including 90% CI's and the works, had it not been for the final punch:
"In studies to determine bioequivalence after a single dose, the parameters to be analysed are AUCt and Cmax."
...so why do they want tmax at all?
EM.
Complete thread:
- Category now obsolete? EMEA on non-parametrics d_labes 2008-08-22 10:37 [Nonparametrics]
- Category now obsolete? EMEA on non-parametricsElMaestro 2008-08-22 13:23
- Category now obsolete? EMEA on non-parametrics Helmut 2008-08-22 13:31
- EMEA statistical gem d_labes 2008-08-22 13:56
- EMEA statistical gem Helmut 2008-08-22 14:04
- EMEA statistical gem d_labes 2008-08-22 13:56