Bioequivalence and Bioavailability Forum

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