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Dafni_C ☆ Cyprus, 2024-01-17 11:00 (537 d 10:32 ago) Posting: # 23829 Views: 3,837 |
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We have performed a bioequivalence study which passed the acceptance criteria. However there is a subject (sequence) effect for for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞. How this can be justified that doesn't affect the study results?  |
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Relaxation ★ Germany, 2024-01-17 13:30 (537 d 08:01 ago) @ Dafni_C Posting: # 23831 Views: 2,904 |
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Dear Dafni_C. Just for clarification of the background. You conducted an ANOVA (or mixed effects model) with the effects "treatment", "sequence" and "period" as well as the effect "subject(sequence)"? And in your "ANOVA"-table the p-value of "subject(sequence)" was found to be statistically significant? There are more qualified persons here, but ... this indicates that the subjects in the trial were different people, so that normally would be expected to be "significant", right? If you mean the "sequence" effect or something else, you may find the information available in the "Articles" (see header at the very top) helpful. Best regards! |
Ing. Helmut Schütz