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

posted by Helmut Homepage - Vienna, Austria, 2013-12-10 14:05  - Posting: # 12028
Views: 6,086

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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