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

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

posted by Helmut – Vienna, Austria, 2013-12-10 13:05 – Posting: # 12028
Views: 6,877

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

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Complete thread:

FDA: Size of bio-batch Helmut 2013-12-10 14:05 [Regulatives / Guidelines]
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