Bioequivalence and Bioavailability Forum • Evaluation of Reference variability

Evaluation of Reference variability [Design Issues]

posted by Nirali – India, 2009-04-13 13:53 (6283 d 00:52 ago) – Posting: # 3515
Views: 6,604

Dear All,

We want to conduct BE replicate study to demonstrate that the within-subject variability for Cmax of the reference compound in the study is >30% for EU regulatory.

To check reference variablity which study design and model shall be used for statistical analysis?

Shall we use 2-period replicate design to assess the inter and intra-subject variability of reference drug, in which reference drug given in both the periods?

Thanks & Regards,
NIRALI

Complete thread:

Evaluation of Reference variabilityNirali 2009-04-13 11:53 [Design Issues]
- Evaluation of Reference variability KR 2009-04-13 14:39
- Evaluation of Reference variability Ravi 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