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

posted by Helmut Homepage – Vienna, Austria, 2013-12-10 14:05 (2908 d 10:38 ago) – Posting: # 12028
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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 🖖
Helmut Schütz
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