Inflation type one error [RSABE / ABEL]

posted by Mikalai  – Belarus, 2019-11-05 18:59  – Posting: # 20750
Views: 912

Dear all,

1. I am not a statistician and struggle to grasp the concept of type one error inflation in the reference-scaled approach. We basically do the same things as in the usual average bioequivalence where we are able to preserve TIE at 5%, but when we expand CI, we have got TIE inflation. What is behind this inflation, philosophically and mathematically? I also bumped into this discussion where some ever argue about whether this concept even exists. https://daniellakens.blogspot.com/2016/12/why-type-1-errors-are-more-important.html I assume this is not related to multiple testing. Also, we have a statistical concept, but do we have any real proof of this concept? Does anyone know products that were initially registered and then withdrawn from the market because their initial bioequivalence had been due to the inflation TIE.
2 Maybe this is not related to SABE but two-stage design, but anyway. What prevents us from using Bonferroni correction in the two-stage adaptive design, instead of rather complicated other statistical approaches?

Thanks in advance

Complete thread:

Activity
 Admin contact
20,346 posts in 4,274 threads, 1,404 registered users;
online 11 (0 registered, 11 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 15:22 CET

Any one who considers arithmetical methods
of producing random digits is, of course,
in a state of sin.    John von Neumann

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