Bioequivalence and Bioavailability Forum • pilot replicate design

pilot replicate design [RSABE / ABEL]

posted by khaoula – Algeria, 2014-11-19 13:00 (4242 d 01:22 ago) – Posting: # 13876
Views: 12,583

Hi everybody !!!

please, If we suspect that gastro-resistant capsules of omeprazole are highly variable drug product, can we do a PILOTE replicate study? to determine the within subject variability of the reference formulation and widening the bioequivalence limits if CV CR > 30%
thank you

Complete thread:

pilot replicate designkhaoula 2014-11-19 12:00
- pilot replicate design ElMaestro 2014-11-19 12:38
  - pilot replicate design khaoula 2014-11-19 14:11
    - N=24?? ElMaestro 2014-11-19 14:29
    - pilot replicate design Helmut 2014-11-19 15:18
      - pilot replicate design khaoula 2014-11-19 15:57
        
        Futile… Helmut 2014-11-20 14:39
        
        new information khaoula 2014-11-21 12:19
        kinetica khaoula 2014-11-22 10:38
        
        kinetica Helmut 2014-11-22 12:43