Correct input data to re-calculate results of 3x3x3 study using lm() [🇷 for BE/BA]

posted by VStus – Poland, 2016-09-12 10:41 (2754 d 00:15 ago) – Posting: # 16632
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Dear BE-proff,

❝ As far as I understood you had studies with several dosages test products and the same reference. Correct? ;-)


Both studies were exploratory pilots to comparative bioavailability of different Test formulations having different in-vitro characteristics (modified release products) versus Reference formulation. Bioequivalence assessment was only supportive.

Test product was developed using different release mechanism than originator, in-vivo performance of different formulation tweaks were assessed based on obtained PK profiles versus in-vitro data.

Regards, VStus

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