Investigation of ... [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-04 10:43 (3209 d 01:47 ago) – Posting: # 16279
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Dear Helmut,

❝ We are performing a comparative bioavailability study (the experiment) and are hoping for bioequivalence (the desired result).


Up to now my understanding of a bioavailability study was: A study with the aim to study the extent of availability in the body, without the aim to show equivalence. F.i. intra-venious application versus oral.

❝ The assessor describes his hobby like this: “If you already know the result (bioequivalence) why do you want to perform a study?” ;-)


IMHO this is a very sophisticated and nitpicking attitude, suitable to wow NLYW :-D.
In the same spirit you can't speak about non-inferiority or superiority studies.
But: "Jedem Tierchen sein Pläsierchen" (rough translation "To each their own"). Especially if it (the beastie) is an assessor.

Regards,

Detlew

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