Biosimilars [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2011-11-24 15:44 (4091 d 12:44 ago) – Posting: # 7714
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Dear VM,

many countries have issued detailed guidelines already. The most comprehensive ones are EMA’s. See the Guidance page and scroll down to

Biotechnological and Biological Products, Biosimilars


Although GLs consider cross-over studies the ‘Gold Standard’ in all (!) studies I have personally seen (and know of from other people as well) a significant sequence effect was observed. Maybe a parallel design is the better option.

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