Bio-batch size for suspensions [Regulatives / Guidelines]

posted by sireen – Jordan, 2015-08-24 07:20 (3140 d 07:04 ago) – Posting: # 15325
Views: 2,337

Dear All,

The emea guideline for bioequivalence, 2010, states that the test product (for oral solid forms) should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified.....What about oral suspensions and powder for suspension, packaged in multiple dose containers....what is the requested Bio-batch size?

I'll appreciate if someone could send me any references on this subject.

Many thanks in advance!
Sireen

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