Hypotheses [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2021-06-19 14:32 (976 d 12:48 ago) – Posting: # 22423
Views: 3,465

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
22,899 posts in 4,806 threads, 1,651 registered users;
22 visitors (0 registered, 22 guests [including 8 identified bots]).
Forum time: 02:21 CET (Europe/Vienna)

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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