Bioequivalence and Bioavailability Forum • Quick Q for my clarification

Quick Q for my clarification [Design Issues]

posted by martin – Austria, 2012-11-06 13:29 (4979 d 02:03 ago) – Posting: # 9510
Views: 6,829

Hi ElMaestro!

Thank you for your quick reply with my attempt to answer the questions:

I was told that this design is standard for this kind of studies (one test and 2 references) and I think that straightforward doubling the sequence was intuitive with the aim to decrease the number of subjects (no power calculations available)

No idea regarding the intra-subject variability but this information may be important for planning upcoming studies

Scaling would be definitely an option if it turns out that the CV>30% (it's a NON-GXP study)

hope this helps

Martin

Complete thread:

Replicated cross over with fixed number of periods martin 2012-11-05 17:31
- Additional information martin 2012-11-06 11:50
  - Quick Q for my clarification ElMaestro 2012-11-06 12:09
    - Quick Q for my clarificationmartin 2012-11-06 12:29
      - 5 periods ElMaestro 2012-11-06 12:43
      - Latin Squares ↔ Williams’ designs Helmut 2012-11-06 14:07
        
        Latin Squares ↔ Williams’ designs Ben 2012-11-07 21:10
        
        Williams’ designs more reliable? d_labes 2012-11-08 08:29
        
        Williams’ designs more reliable? Ben 2012-11-09 18:20
        
        Williams’ designs more reliable? d_labes 2012-11-11 14:14
        
        Williams’ designs more reliable? Ben 2012-11-18 13:20
        
        Frequentists vs. Bayesians Helmut 2012-11-18 14:48
        
        Frequentists vs. Bayesians Ben 2012-11-18 15:28