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

posted by Mauricio Sampaio  – Brazil, 2016-11-11 19:39 (3018 d 20:05 ago) – Posting: # 16797
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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! :cool:

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