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

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

posted by Helmut - Vienna, Austria, 2013-12-10 14:05 - Posting: # 12028
Views: 5,433

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.

—
Cheers,
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. ☼
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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
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        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 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

Bioequivalence and Bioavailability Forum 14:28 CET

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

Complete thread: