Sample size for PK linearity [Power / Sample Size]
Hi,
I would like to estimate a sample size for a PK linearity study.
The study design plans to test 4 different doses (10, 20, 30 and 40).
I need to test the bioequivalence for each dose, compared to the reference dose which is 20. In addition I need to calculate the linear correlation slope for the four doses, a deviation of 20% between doses being acceptable.
What is the required methodology and what is the formula to calculate the sample size?
Regards,
Kro
I would like to estimate a sample size for a PK linearity study.
The study design plans to test 4 different doses (10, 20, 30 and 40).
I need to test the bioequivalence for each dose, compared to the reference dose which is 20. In addition I need to calculate the linear correlation slope for the four doses, a deviation of 20% between doses being acceptable.
What is the required methodology and what is the formula to calculate the sample size?
Regards,
Kro
Complete thread:
- Sample size for PK linearityKro 2009-05-19 10:56 [Power / Sample Size]
- Sample size for PK linearity Helmut 2009-05-19 13:19
- Sample size for PK linearity Kro 2009-05-19 13:56
- Sample size for PK linearity Helmut 2009-05-19 15:09
- Sample size for PK linearity ElMaestro 2009-05-26 17:26
- Weighting scheme Helmut 2009-05-26 19:52
- Sample size for PK linearity mjons 2011-12-08 18:03
- Sample size for PK linearity Lucas 2014-09-11 21:41
- Sample size for PK linearity - power model d_labes 2014-09-12 15:01
- Power dose proportionality - power model - Correction d_labes 2014-10-01 09:09
- Sample size for PK linearity d_labes 2014-09-13 15:05
- Sample size for PK linearity Lucas 2014-10-13 20:36
- Sample size for PK linearity d_labes 2014-10-14 09:26
- Sample size for PK linearity Lucas 2014-10-14 15:24
- Sample size for PK linearity d_labes 2014-10-14 09:26
- Sample size for PK linearity Lucas 2014-10-13 20:36
- Sample size for PK linearity - power model d_labes 2014-09-12 15:01
- Sample size for PK linearity ElMaestro 2009-05-26 17:26
- Sample size for PK linearity Helmut 2009-05-19 15:09
- dose proportionality vs. dose linearity martin 2009-05-25 08:46
- dose proportionality vs. dose linearity Helmut 2009-05-25 14:59
- Sample size for PK linearity Kro 2009-05-19 13:56
- Sample size for PK linearity Helmut 2009-05-19 13:19