Biosimilars [Design Issues]

posted by Ben – 2011-12-16 20:04 (4069 d 08:55 ago) – Posting: # 7784
Views: 4,580

Dear Helmut/all,

you wrote

❝ 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.


Is there a specific reason why this is so? I mean, this sounds like the problem of having a sequence effect always occurs when having biosimilars. What is so "special" about them causing sequence (or carryover or trt*prd interaction) effects?

Thanks,
Ben

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