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RegisterBio-batch size for suspensions [Regulatives / Guidelines]
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
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
Complete thread:
- Bio-batch size for suspensionssireen 2015-08-24 05:20
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