Hypotheses [Outliers]

posted by Loky do – Egypt, 2021-07-06 11:51 (354 d 15:25 ago) – Posting: # 22458
Views: 1,189

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

Complete thread:

UA Flag
Activity
 Admin contact
22,167 posts in 4,645 threads, 1,572 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Sunday 03:16 CEST (Europe/Vienna)

The person interested in success has to learn
to view failure as a healthy, inevitable part
of the process of getting to the top.    Joyce Brothers

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5