Bioequivalence and Bioavailability Forum • Randomization access

Randomization access [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2015-08-10 11:51 (3973 d 22:40 ago) – Posting: # 15208
Views: 5,901

Hi bkrao,

❝ My question is whether the treatment randomization is accessable to the bioanalytical persons before the intioation of the bioanalytial phase.

Usually, BE studies are open-label and control of the rand. code is thus not extremely crucial, but it is a good habit in the industry to keep the rand. code away from bioanalysts. Most companies I know of state that bioanalysts are actually kept blind, both in protocols and SOPs. I think this is a very healthy principle but it is not specifically regulated by a guideline.

—
Pass or fail!
ElMaestro

Complete thread:

Randomization access bkrao 2015-08-10 07:24
- Randomization access BE-proff 2015-08-10 08:38
  - Randomization access bkrao 2015-08-10 08:51
    - Randomization access BE-proff 2015-08-10 09:41
    - Randomization accessElMaestro 2015-08-10 09:51
      - Randomization access bkrao 2015-08-10 10:18
        
        Result oriented? Analyst driven? ElMaestro 2015-08-10 10:53
        
        Result oriented? Analyst driven? bkrao 2015-08-10 13:22
        
        Relax Helmut 2015-08-10 18:33
        
        Thanks you bkrao 2015-08-11 05:44
- Randomization access Ohlbe 2015-08-17 18:14