open-label BE trials maintain blindness [Study Per­for­mance]

posted by kimhuang – China, 2023-10-18 02:50 (130 d 14:33 ago) – Posting: # 23762
Views: 1,180

❝ 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
22,911 posts in 4,806 threads, 1,635 registered users;
30 visitors (0 registered, 30 guests [including 5 identified bots]).
Forum time: 16:23 CET (Europe/Vienna)

The history of statistics is like a telephone directory:
the plot is boring, full of numbers and the cast is endless.    Stephen Senn

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