sireen ☆ Jordan, 2015-08-24 07:20 (3166 d 22:29 ago) Posting: # 15325 Views: 2,374 |
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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 |