Bioequivalence and Bioavailability Forum • Evaluation of Reference variability

Evaluation of Reference variability [Design Issues]

posted by Ravi – India, 2009-04-14 08:25 (5849 d 08:51 ago) – Posting: # 3519
Views: 4,034

Dear Nirali,

To check for reference variablity you can use modified replicate design i.e. 3 period, 3 sequence and 2 treatment crossover design with sequences as RTR, RRT, TRR. But this design will provide you with intra CV for reference only. For more details please have alook at
Bioequivalence Approaches for Highly Variable Drugs and Drug Products by Sam H. Haidar.

I hope this helps.

—
Thanks & Regards
Ravi Pandey

Complete thread:

Evaluation of Reference variability Nirali 2009-04-13 11:53 [Design Issues]
- Evaluation of Reference variability KR 2009-04-13 14:39
- Evaluation of Reference variabilityRavi 2009-04-14 06:25
  - Evaluation of Reference variability Nirali 2009-04-17 07:38
    - Evaluation of Reference variability Ohlbe 2009-04-17 10:04
    - Evaluation of Reference variability Helmut 2009-04-17 13:44
      - Evaluation of Reference variability Nirali 2009-04-18 09:04
        
        Evaluation of Reference variability Helmut 2009-04-18 12:31
        
        Evaluation of Reference variability Nirali 2009-04-18 19:34
      - Evaluation of Reference variability Marcel 2010-03-16 13:10
        
        Evaluation of Reference variability Helmut 2010-03-16 16:01
        
        Evaluation of Reference variability ElMaestro 2010-03-16 17:13
        
        Some desultory thoughts Helmut 2010-03-16 18:59
        
        Evaluation of Reference variability Marcel 2010-03-17 12:47