Bioequivalence and Bioavailability Forum • Type II variation

Type II variation [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2018-06-22 15:12 (1507 d 12:40 ago) – Posting: # 18948
Views: 7,469

Hi Beholder,

» […] whether we need to perform BEQ study in case of changes in amount of tablets in production batch or not? I refer to the table B.II.b.4 Change in the batch size (including batch size ranges) of the finished product

Yes because that’s a Type II (i.e., a major) variation. Only if the conditions for a biowaiver are applicable you could get around an in vivo study.

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Helmut Schütz

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Complete thread:

FDA: Size of bio-batch Helmut 2013-12-10 14:05 [Regulatives / Guidelines]
- FDA: Size of bio-batch jag009 2013-12-10 20:03
  - FDA: antique of ’93 Helmut 2013-12-10 23:32
    - FDA: antique of ’93 jag009 2013-12-11 15:23
      - FDA: antique of ’93 Helmut 2013-12-11 15:26
        
        FDA: antique of ’93 jag009 2013-12-11 16:21
        
        FDA: antique of ’93 Helmut 2013-12-11 16:29
        
        FDA: antique of ’93 jag009 2013-12-11 23:16
        
        Patience Helmut 2013-12-12 14:34
    - FDA: antique of ’93 Beholder 2018-06-21 09:21
      - Nice numbers Helmut 2018-06-21 15:05
        
        Nice numbers Beholder 2018-06-22 10:33
        
        Type II variationHelmut 2018-06-22 15:12
      - Birdsong's third law of BE ElMaestro 2018-06-22 10:10
        
        Experience Beholder 2018-06-22 11:04
        
        Why, oh why? Helmut 2018-06-22 15:17
        
        Sorry for the delay Beholder 2018-10-18 09:40