ABSTRACT
To receive approval for an abbreviated new drug application (aNDA), applicants generally must demonstrate, among other things, that their product has the same active ingredient, dosage form, strength, route of administration, and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug. Bioequivalence (BE) studies are undertaken in support of aNDA submissions with the goal of demonstrating BE between a proposed generic drug product and its reference listed drug. Pharmaceutical manufacturers are encouraged to submit protocols for the in vivo BE studies to be conducted at steady state in patients already taking the reference listed drug at a therapeutic dose for review prior to initiating the studies. To streamline the process for making guidance available to the public on how to design product-specific BE studies, the US Food and Drug Administration will be issuing product-specific BE recommendations.
