Not more than 2 sequences in full replicates [Design Issues]
Hi Helmut...
YES!!!!
Thank you so much. Really, 2 more sequences are a waste of time to prove a bioequivalence result!
❝ 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 [Design Issues]
- 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
- Not more than 2 sequences in full replicates Astea 2016-11-04 08:22
- Not more than 2 sequences in full replicates Helmut 2016-11-03 19:38