Bioequivalence and Bioavailability Forum

Not more than 2 sequences in full replicates [Design Issues]

posted by Mauricio Sampaio  – Brazil, 2016-11-11 19:39 (3517 d 17:29 ago) – Posting: # 16797
Views: 6,688

Hi Helmut...

❝ To clarify: By 4×2 do you mean RTRT|TRTR and by 4×4 RTRT|TRTR|RRTT|TTRR or yet another one (e.g., TRRT|RTTR|TTRR|RRTT)?

YES!!!!

❝ But: IIRC, in the late 1990 Donald Schuirmann argued against more than two sequences in full replicate designs. See also Appendix B of the FDA’s guidance.

Thank you so much. Really, 2 more sequences are a waste of time to prove a bioequivalence result!

Complete thread:

• Any post about difference between 4x4 and 4x2 in bioequivalence studies? Mauricio Sampaio 2016-11-03 18:54 
  • Not more than 2 sequences in full replicates Helmut 2016-11-03 19:38
    • Not more than 2 sequences in full replicates Astea 2016-11-04 08:22
      • Only RR is used Helmut 2016-11-11 20:52
    • Not more than 2 sequences in full replicatesMauricio Sampaio 2016-11-11 18:39