Bioequivalence and Bioavailability Forum

Replicate design [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2011-04-21 15:04 (5137 d 23:37 ago) – Posting: # 6931
Views: 9,234

Hello Andrew,

❝ To my mind, it should be possible (in theory, at least) to make a BE comparison of Reference vs Reference (or Test vs Test) from the data derived from a BE study with a 4-period replicate design. Despite being a statistical epsilon semi-moron, I can still see that there must be a problem with the fact that in this design each volunteer receives the second dose of Reference after the first dose of Reference (doh!), whether they received the sequence TRTR or RTRT. In other words, there is only one sequence for Reference (or Test). Presumably this must interfere with proper determination of BE. How should one deal with this?

"A cosmic mind-f#%&er" as one of my sailors would call it.
If I understand your post correctly, your worry seems to be whether patient X is in sequence RR or in sequence RR . Sequence, however, is a between-factor. Try and run the standard model without sequence as a factor on your ref data. And try for comparison to run a normal 2-period study without Sequence as a factor.

Complete thread:

• Replicate design Dr Andrew Leary 2011-04-21 11:50 
  • Replicate designElMaestro 2011-04-21 13:04
    • Replicate design Dr Andrew Leary 2011-04-21 21:53
    • Replicate design AGAIN Dr Andrew Leary 2011-04-27 12:21
      • Replicate design limbo Helmut 2011-04-27 13:43
        • Replicate design limbo Dr Andrew Leary 2011-04-27 16:11
          • Replicate design limbo Helmut 2011-04-27 16:52
            • Replicate design Vienna waltz d_labes 2011-04-28 08:54
              • Replicate design EMA Morris dance Helmut 2011-04-28 14:17
                • EMA Morris dance d_labes 2011-05-02 12:55