Imbalanced cross-overs [Study Per­for­mance]

posted by khaoula – Algeria, 2014-06-06 18:03 (3583 d 20:46 ago) – Posting: # 13039
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Hi Helmut,

❝ I don’t understand what you mean here. The limit for HVDs/HVDPs is 30% CV of the reference obtained in a replicate design. CVintra from a 2×2 serves only as a hint of a highly variable reference (since pooled from CVWR and CVWT).


this is a real study that was done in the institute were I do my post graduate disertation, and the drug is omeprazole, that is a HVDP (in bibliography I read a lot of bioequivalence stydy were CV > 30%) I know that the cross over isn't adapted for this, but CV C max of the study Was very low!!!!!!!!

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