Bioequivalence and Bioavailability Forum • Randomization access

Randomization access [Regulatives / Guidelines]

posted by Ohlbe – France, 2015-08-17 20:14 (3967 d 07:53 ago) – Posting: # 15287
Views: 5,589

Dear Balaga,

❝ Is there is any restriction that the bioanalytical department should not be accessable to randomization schedule? If so, please let me know the source guidelines.

EMA BE guideline, § 4.1.7, last line:
Analysis of samples should be conducted without information on treatment.

—
Regards
Ohlbe

Complete thread:

Randomization access bkrao 2015-08-10 07:24
- Randomization access BE-proff 2015-08-10 08:38
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    - Randomization access ElMaestro 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 accessOhlbe 2015-08-17 18:14