Bioequivalence and Bioavailability Forum • Evaluation of Reference variability

Evaluation of Reference variability [Design Issues]

posted by KR – India, 2009-04-13 16:39 (6285 d 07:51 ago) – Posting: # 3517
Views: 5,781
(edited on 2009-04-14 10:39)

Dear Nirali,

You can use partial replicate study in which two reference and one test formulation are given to evaluate variablity of Cmax.
For details, see the Helmut's post on "Reference scaled approach for HVD".

KR
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Edit: Full quote removed. Please see this post! [Ohlbe]

Complete thread:

Evaluation of Reference variability Nirali 2009-04-13 11:53 [Design Issues]
- Evaluation of Reference variabilityKR 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