Sample size calculation [RSABE / ABEL]
Hi All,
Let's say I want to calculate sample size for a BE-study using the following data:
CVintra of Cmax= 39.8%
Power= at least 80%
GMR = 1.15
I want to utilize 2x2x4 design with reference scaling and PowerTOST gives me:
Is it correct that:
- at least 48 subjects to be randomized
- CI for Cmax is 0.74 - 1.34
- CIs for AUCs are 0.80-1.25
Let's say I want to calculate sample size for a BE-study using the following data:
CVintra of Cmax= 39.8%
Power= at least 80%
GMR = 1.15
I want to utilize 2x2x4 design with reference scaling and PowerTOST gives me:
library(PowerTOST)
sampleN.scABEL.ad(CV=0.398, theta0=1.15, targetpower=0.80, design="2x2x4")
+++++++++++ scaled (widened) ABEL +++++++++++
Sample size estimation
for iteratively adjusted alpha
---------------------------------------------
Study design: 2x2x4 (RTRT|TRTR)
log-transformed data (multiplicative model)
1,000,000 studies in each iteration simulated.
Expected CVwR 0.398
Nominal alpha : 0.05
True ratio : 1.1500
Target power : 0.8
Regulatory settings: EMA (ABEL)
Switching CVwR : 0.3
Regulatory constant: 0.76
Expanded limits : 0.7472...1.3383
Upper scaling cap : CVwR > 0.5
PE constraints : 0.8000 ... 1.2500
n 48, adj. alpha: 0.04444 (power 0.8100), TIE: 0.05000
Is it correct that:
- at least 48 subjects to be randomized
- CI for Cmax is 0.74 - 1.34
- CIs for AUCs are 0.80-1.25
Complete thread:
- Sample size calculationBE-proff 2016-12-14 08:56
- Sample size estimation for iteratively adjusted α Helmut 2016-12-14 16:24
- Sample size estimation for iteratively adjusted α BE-proff 2016-12-14 19:43
- Sample size estimation for iteratively adjusted α BE-proff 2016-12-20 21:47
- (1-2*alpha) CI d_labes 2016-12-21 11:15
- Script kiddy Helmut 2016-12-21 18:09
- (1-2*alpha) CI d_labes 2016-12-21 11:15
- Sample size estimation for iteratively adjusted α Helmut 2016-12-14 16:24