failed bioequivalence study [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2009-05-24 16:48 (6246 d 06:53 ago) – Posting: # 3743
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Hi AMR,

❝ the geometric mean ratio for main pK parameters was less than 80%


It sounds to me like the formulations are not really equivalent, so reformulation is imho the way forward.

Best regards
EM.

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