Bioequivalence and Bioavailability Forum • Randomization access

Randomization access [Regulatives / Guidelines]

posted by bkrao – India, 2015-08-10 09:24 (3969 d 18:29 ago) – Posting: # 15200
Views: 6,838

Hi,
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.

My exact intention is whether the person who knows the randomization schedule can be able to perform the bioanalytical activities also? Is there any regulatory violation.?Kindly clarify. If so, then let me know the respective guidance with respect to the same provison.

I hope randomization shcdule must be blinded to the bioanalytical department before bio analysis to avoid the bias.

I egarly awaited for your valubale suggestions.

Thanks & Regards,
Balaga Koteswara Rao.
Cadila Pharmaceuticals Ltd.

Complete thread:

Randomization accessbkrao 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 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 access Ohlbe 2015-08-17 18:14