Bioequivalence and Bioavailability Forum • Sample size and Replicated studies

Sample size and Replicated studies [Power / Sample Size]

posted by Bebac user – Egypt, 2022-03-23 10:38 (763 d 10:06 ago) – Posting: # 22860
Views: 3,076

Partially replicated study, I use this code for sample size estimation

sampleN.scABEL(CV=0.3532)



+++++++++++ scaled (widened) ABEL +++++++++++

            Sample size estimation

   (simulation based on ANOVA evaluation)

---------------------------------------------

Study design: 2x3x3 (partial replicate)

log-transformed data (multiplicative model)

1e+05 studies for each step simulated.



alpha  = 0.05, target power = 0.8

CVw(T) = 0.3532; CVw(R) = 0.3532

True ratio = 0.9

ABE limits / PE constraint = 0.8 ... 1.25

EMA regulatory settings

- CVswitch            = 0.3

- cap on scABEL if CVw(R) > 0.5

- regulatory constant = 0.76

- pe constraint applied





Sample size search

 n     power

45   0.7829

48   0.8045

But, I know that I can't use more than 40 volunteers in any BE study

In these cases, what should I do ?

Complete thread:

Sample size and Replicated studiesBebac user 2022-03-23 09:38
- Sample size and Replicated studies dshah 2022-03-23 11:30
  - Output of sampleN.scABEL() Helmut 2022-03-23 12:43
    - Output of sampleN.scABEL() - expanded limits ? d_labes 2022-03-23 16:33
      - Output of sampleN.scABEL() - expanded limits ? Helmut 2022-03-23 16:45
    - Output of sampleN.scABEL() dshah 2022-03-23 18:08
      - Don’t use FARTSSIE for SABE Helmut 2022-03-23 19:42
- Sample size larger than clinical capacity Helmut 2022-03-23 11:43
- Sample size and Replicated studies Brus 2022-03-23 14:25