Bioequivalence and Bioavailability Forum • Replicate Study Designs

Replicate Study Designs [Design Issues]

posted by Helmut – Vienna, Austria, 2012-07-09 17:27 (5094 d 18:04 ago) – Posting: # 8911
Views: 4,175

Dear Kotu!

From a purely (!) statistical point of view a full replicate design is ‘better’ because you get not only insights on the reference’s intra-subject variability but also of the test’s.
Not clear what you mean here. The pilot study should be a replicate as well (we have no Two-Stage Method yet). You should plan for power of 80–90%. Most people plan for 90% (best case: everything as expected) and try the keep the worst-case power (CV, PE, number of drop-outs) not far below 80%. Note that ‘classical’ sample size estimation is not applicable (GMR-restriction, 50% cut-off for EMA). Unless your set up your own simulations, see Endrényi & Tóthfalusi (2011).^*
See #1. One more period in the full replicate increases the chance of drop-outs. Might require to improve the bioanalytics (less plasma per individual sample since total blood volume in the study is limited to ~500 mL).
See #3 and this presentation.

László Endrényi, László Tóthfalusi
Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs
J Pharm Pharmaceut Sci 15(1), 73–84 (2011)
online

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Replicate Study Designs balakotu 2012-07-09 09:16
- Replicate Study DesignsHelmut 2012-07-09 15:27