Terminology [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2017-02-18 16:27 (1264 d 15:30 ago) – Posting: # 17086
Views: 10,671

Hi BE-proff,

» Rather risky - such methods must be present in our guides otherwise our designs will be rejected...

“Type 1” or “Type 2” was my proposal to introduce an unambiguous terminology. Get the paper at sci-hub. ;-)
On the contrary the Russian guideline (copypasted from the EMA’s) is ambigous (“For example, using 94.12% confidence intervals […] would be acceptable, but there are many acceptable alternatives and the choice of how much alpha to spend at the interim analysis is at the company's discretion”).

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,969 posts in 4,374 threads, 1,461 registered users;
online 20 (1 registered, 19 guests [including 13 identified bots]).
Forum time: Thursday 08:57 CEST (Europe/Vienna)

It is a good morning exercise for a research scientist
to discard a pet hypothesis every day before breakfast.
It keeps him young.    Konrad Lorenz

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