Bioequivalence and Bioavailability Forum • FDA: Size of bio-batch

FDA: Size of bio-batch [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-12-10 15:05 (3784 d 01:25 ago) – Posting: # 12028
Views: 14,396

Dear all,

for pivotal BE studies EMA requires that

The test product should usually originate from a batch of ≥1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified.

Do you know of a corresponding requirement by the FDA? In the Summary Table 11 sizes of the bio-batch and production batch have to be reported.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

FDA: Size of bio-batchHelmut 2013-12-10 14:05
- FDA: Size of bio-batch jag009 2013-12-10 20:03
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        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 variation Helmut 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