Bioequivalence and Bioavailability Forum

open-label BE trials maintain blindness [Study Performance]

posted by kimhuang – China, 2023-10-18 02:50 (452 d 23:04 ago) – Posting: # 23762
Views: 3,131

❝ 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:

open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Performance]
- Blinded NCA Helmut 2023-10-14 10:40
  - Blinded NCA kimhuang 2023-10-14 11:53
    - Blinded review of PK data: History… Helmut 2023-10-15 10:26
      - Blinded review of PK data: History… kimhuang 2023-10-16 00:43
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39
  - open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
    - open-label BE trials maintain blindness dshah 2023-10-17 09:25
      - open-label BE trials maintain blindnesskimhuang 2023-10-18 00:50

open-label BE trials maintain blindness [Study Per­for­mance]

Complete thread:

open-label BE trials maintain blindness [Study Performance]