Bioequivalence and Bioavailability Forum

open-label BE trials maintain blindness [Study Performance]

posted by dshah – India, 2023-10-17 11:25 (364 d 00:34 ago) – Posting: # 23760
Views: 2,744

Hi kimhuang!

❝ Per protocol, bioanalytical staff is blinded,others is not mentioned in protocol, but study team discuss PK parameters (without treatment assignment,such as Pre-dose concentration, abnormal PK concentration profiles, λz estimation, %AUCextrap etc.) to decide analysis set in data review meeting before database lock.

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.

❝ ❝ 3. Who has access to the rand. code? I do not mean who should have access.

❝ As it's an open-label BE study, CRF collect treatment sequence, so study team can access to the treatment assigment.

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

Regards,
Divyen

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 blindnessdshah 2023-10-17 09:25
      - open-label BE trials maintain blindness kimhuang 2023-10-18 00:50

open-label BE trials maintain blindness [Study Per­for­mance]

Complete thread:

open-label BE trials maintain blindness [Study Performance]