Terminology [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2017-02-18 17:27 (2617 d 18:11 ago) – Posting: # 17086
Views: 12,979

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 🖖🏼 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
22,988 posts in 4,825 threads, 1,657 registered users;
88 visitors (0 registered, 88 guests [including 4 identified bots]).
Forum time: 12:38 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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