Bioequivalence and Bioavailability Forum • Evaluation of Reference variability

Evaluation of Reference variability [Design Issues]

posted by Helmut – Vienna, Austria, 2009-04-17 15:44 (6275 d 12:13 ago) – Posting: # 3555
Views: 5,619

Dear Nirali,

I agree with Ohlbe. Same opinions were expressed at the EUFEPS meeting last January (see this thread), where almost the entire PK group of EMEA was present. The group univocally expressed their point of view that a two period replicate design (reference only) is not acceptable. See also Jan Welink's presentation (slide 22).
On the other hand I know of European companies running such studies right now (despite clear reservations by regulators). Obviously these companies are sure that they will be able to convince authorities that the performance was not sloppy. I would not bet on their success!

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Helmut Schütz

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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 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 variabilityHelmut 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