Hypotheses [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2021-06-19 14:32 (1129 d 13:33 ago) – Posting: # 22423
Views: 4,694

Hi Loky do,

in addition to what Mittyri and Dr Gunasakaran wrote, a general remark about confirmatory studies:
  1. You state a null hypothesis H0 and an alternative hypothesis H1.
    In bioequivalence H0 is inequivalence – which you desire to reject.
  2. You state an appropriate statistical method, most commonly the confidence inclusion approach.
  3. You perform the study and assess #1 by #2.
    The outcome is dichotomous, i.e., either the study passed (H0 rejected) or it failed (H0 not rejected).
What you must not do: The study failed according to the planned conditions and then you change #1 and/or #2 in order to make it pass. That’s the cherry-picking Mittyri was talking about.
In simple terms: The entire \({\small{\alpha=0.05}}\) was already ‘spent’ in the original analysis. Hence, any ‘alternative’ evaluation will increase the patient’s risk, which is not acceptable.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,113 posts in 4,858 threads, 1,644 registered users;
53 visitors (0 registered, 53 guests [including 9 identified bots]).
Forum time: 04:06 CEST (Europe/Vienna)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different.    Anthony Burgess

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