Bioequivalence and Bioavailability Forum • Randomization for Replicate design studies

Randomization for Replicate design studies [Design Issues]

posted by Helmut – Vienna, Austria, 2020-04-20 12:18 (108 d 03:31 ago) – Posting: # 21338
Views: 560

Hi MMW,

» Once of the clients want to conduct the partial replicate BE study with two test products (T1 & T2) in comparison with reference product (R).

More information, please. Will this be a pilot study where you want to select one of the candidates or a pivotal study (say, T1 is a tablet, T2 a capsule and you want to market both)?

For the former see this presentation (slide 22).
For the latter employ the same design but adjust for multiplicity (i.e., 95% CI, slide 23).
If you expect a CV_wR <43% the Type I Error might be inflated. You can iteratively adjust α (see here and there) with the R-package PowerTOST. Call scABEL.ad(alpha = 0.025, design = "2x3x3", ...), where in ... you provide the observed CV_wR and sample size (in the case of drop-outs: subjects/sequence). In case of unbalanced sequences use the argument sdsims = TRUE (slower but more accurate).

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Complete thread:

Randomization for Replicate design studies mmw 2020-04-18 13:43 [Design Issues]
- Randomization for Replicate design studiesHelmut 2020-04-20 12:18
  - Randomization for Replicate design studies mmw 2020-04-28 09:27