Bioequivalence and Bioavailability Forum

Replicate design [RSABE / ABEL]

posted by Dr Andrew Leary – Ireland, 2011-04-21 13:50 (5120 d 03:51 ago) – Posting: # 6929
Views: 10,810

Greetings Helmut et al from sunny Ireland!

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?

Kind regards

Andrew Leary

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Edit: Category changed. [Helmut]

Complete thread:

• Replicate designDr Andrew Leary 2011-04-21 11:50 [RSABE / ABEL] 
  • Replicate design ElMaestro 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