Two-stage (any method) and multiplicity [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2011-10-30 19:26 (4615 d 15:44 ago) – Posting: # 7560
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Dear HS,

❝ Opinions, ideas?


There are quite a few SPC's out there which state dose proportionality or dose linearity and where the originator as far as I know hasn't really done that fancy stuff but just administered a series of doses and checked AUC or Cmax or Cl. That's good enough isn't it.
At least for EU, I guess part of the story is to live with the BE-guideline's requirement "Assessment of linearity will consider whether differences in dose-adjusted AUC meet a criterion of ± 25%." which can be dealt with very simply.
Perhaps your angle is different and that where the complexity comes in? I am eager to hear.

Btw, in spite of the links to previous definitions and discussions I still think we need some useful definitions, preferably in guidelines. Cmax etc vs dose being a straight line, I am perfectly willing to call that linearity; Wikipedia does an excellent job at confusing readers.

Pass or fail!
ElMaestro

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