Failed study [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-04-27 02:33 (1533 d 12:34 ago) – Posting: # 22328
Views: 4,280

Hi mittyri,

❝ what is the proposed solution for such situation?

❝ say the subject did not swallow the IMP (just for fun) and investigators missed that.

❝ There's no way to prove this without direct subject's confession. Game over? The study failed?


Yep. To quote myself:

»[…] we cannot distinguish between lack of compliance (the subject didn’t take the drug), a product failure, and a subject-by-formulation interaction (the subject belongs to a subpopulation).«


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
23,428 posts in 4,929 threads, 1,698 registered users;
117 visitors (0 registered, 117 guests [including 33 identified bots]).
Forum time: 15:07 CEST (Europe/Vienna)

Anyone who conducts an argument by appealing to authority
is not using his intelligence;
he is just using his memory.    Leonardo da Vinci

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