Multiple dose design Sample size [Power / Sample Size]
Dear Researcher 101,
If you have performed any single dose study, its best to perform Superposition as per SmPC/ PI instruction. Then perform the stat at Steady state- you will know the %CV for all the required parameter and then take a call.
Mostly- based on theoretical assumption, the %CV will come less in multi dose for this phenomena.
Regards,
DShah
If you have performed any single dose study, its best to perform Superposition as per SmPC/ PI instruction. Then perform the stat at Steady state- you will know the %CV for all the required parameter and then take a call.
Mostly- based on theoretical assumption, the %CV will come less in multi dose for this phenomena.
Regards,
DShah
Complete thread:
- Multiple dose design Sample size Researcher101 2020-10-14 10:21 [Power / Sample Size]
- CV of Css,max ≤ CV of Cmax Helmut 2020-10-14 11:27
- Multiple dose design Sample size Researcher101 2020-10-14 13:37
- Sample size based on worst case Helmut 2020-10-19 16:17
- Multiple dose design Sample sizedshah 2020-10-20 06:43