Bioequivalence and Bioavailability Forum • BCS-based Biowaiver

BCS-based Biowaiver [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2008-09-25 17:48 (6053 d 16:12 ago) – Posting: # 2408
Views: 23,587

Dear all!

BCS-based Biowaiver, IV.1.1 General aspects, page 26 (lines 985-990)
'Comparative in vitro dissolution experiments should follow current compendial standards. [...] Usual experimental conditions are e.g.: [...]

Volume of dissolution medium: 500 ml'

No, usual compendial standards are not 500 ml, but 250 ml! We know that guidelines easily are interpreted as laws, both by regulators and the industry - what now? Follow pharmacopeias and perform the test in 250 ml (and rely on the 'e.g.' before 500 ml), or discard all established methods and develop new ones in 500 ml media?
BTW, 500 ml are in contradiction to all (?) references published on the BCS...

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Helmut Schütz

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Complete thread:

Critical review of EU BE guideline (Rev.1) Helmut 2008-08-22 14:30 [Regulatives / Guidelines]
- Critical review of EU BE guideline (Rev.1) d_labes 2008-08-22 15:42
  - Critical review of EU BE guideline (Rev.1) Helmut 2008-08-23 02:02
    - Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 09:14
      - Variations Helmut 2008-08-25 11:06
- Critical review of EU BE guideline (Rev.1) Jaime_R 2008-08-23 16:47
  - Critical review of EU BE guideline (Rev.1) Ravi 2008-08-25 08:19
    - Two Stage Design Helmut 2008-08-25 11:43
      - Two Stage Design JPL 2008-08-28 09:44
        
        Two Stage Design Helmut 2008-08-28 11:50
        
        Two Stage Design d_labes 2008-08-28 12:09
        Sequential Design Helmut 2008-11-05 13:22
  - Critical review of EU BE guideline (Rev.1) banusunman 2008-08-26 16:56
    - Washout Helmut 2008-10-15 16:02
- Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 09:49
  - Critical review of EU BE guideline (Rev.1) Helmut 2008-08-25 12:11
    - Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 13:03
    - Urban legend? Helmut 2008-11-21 16:06
      - Urban legend? d_labes 2008-11-24 15:06
- Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 11:16
- Critical review of EU BE guideline (Rev.1), tmax, MRT, LZ d_labes 2008-08-25 11:32
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      - tmax, Canadian approach Helmut 2008-11-21 15:41
        
        tmax, Canadian approach d_labes 2008-11-24 13:53
        
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        Early exposure, Canadian approach: GMR only! d_labes 2009-02-09 08:50
        
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      - Manual reintegration! ElMaestro 2008-08-28 12:44
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  - HVDs? Helmut 2009-01-20 14:33
  - E.g., omeprazole Helmut 2009-03-06 17:21
- BCS-based BiowaiverHelmut 2008-09-25 15:48
  - Dissolution update Helmut 2008-10-13 12:43
- EUFEPS workshop Helmut 2008-12-23 17:03