bioequivalence - biocomparability [Regulatives / Guidelines]

posted by Ohlbe – France, 2008-08-27 16:56 (6515 d 05:04 ago) – Posting: # 2264
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Dear Martin,

OK, this is much clearer now ! I never think of these bio-generics.

I am no statistician, so I am probably not the best person to answer. But I note that the definition in the guideline mentions "similar", which you translate with "equivalent" in your own definition. Does this make any difference in the stat tests used ?

Regards
Ohlbe

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