ABEL: Type I Error [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-09-28 17:12 (601 d 05:45 ago) – Posting: # 21947
Views: 1,237

Dear all,

we know for a good while that under certain conditions the Type I Error (TIE) might be inflated. However, seemingly European assessors were either not aware of it or ignored it. Last week I saw a deficiency letter (don’t ask for the country):

… in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds.


Kudos! Almost correct. The area of inflated TIEs may reach below 30% and only rarely (say, for a 4-period full replicate in 24 subjects) to 45%.

Dif-tor heh smusma 🖖 [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
22,091 posts in 4,630 threads, 1,566 registered users;
online 23 (0 registered, 23 guests [including 19 identified bots]).
Forum time: Sunday 22:58 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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