Hypotheses [Outliers]

posted by Loky do – Egypt, 2021-07-06 11:51 (20 d 13:59 ago) – Posting: # 22458
Views: 266

Thanks, Helmut for your reply

but I am quite confused, some products show high intrasubject variability more than anticipated or published in the literature and I think this variability affect the reliability of results, for example, I have a BE study for (lansoprazole), partially replicate design, the published intrasubject variability ~ 40% but the practical intrasubject variability we had was near 85% :confused: study protocol also stated using ema guidelines for scaling but the study failed, when I used FDA method it passes :confused: does this high variability have a role in this confusing results? also in the future protocol can I specify that if the intrasubject variability is more than 50% can I switch to the FDA method for calculation, as many authorities we submit our studies to follow ema guidelines?

Thanks in advance

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