open-label BE trials maintain blindness [Study Per­for­mance]

posted by kimhuang – China, 2023-10-18 02:50 (579 d 20:41 ago) – Posting: # 23762
Views: 3,902

❝ So there are no SOP w.r.t. pre-dose concentration, abnormal PK concentration, λz estimation? Generally QA goes ahead with protocol inclusion/exclusion criteria and SOP of BA.


there's no SOP about handing these cases, case-by-case discuss in blinded data review meeting.

❝ Does BA team also have access to CRF? Then how it is blinded?


BA is blinded.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,682 registered users;
91 visitors (0 registered, 91 guests [including 16 identified bots]).
Forum time: 23:31 CEST (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

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