A new formulation under investigation was planned to be submitted for use in both the US and Europe. As the reference formulation in the US differs from that in Europe, two separate bioequivalence studies were needed to gain approval from the FDA and EMA. Study 1 was conducted for FDA approval and successfully demonstrated bioequivalence. Study 2 was conducted for EMA approval and whilst AUC was within the bioequivalence limits, Cmax was not, and bioequivalence could not formally be declared.
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