USA – FDA testing bioequivalence data assessment tool

FDA leaders are experimenting on new programs that innovate how technology facilitates the review and approval of new drugs.

Offices within the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) are developing new tools to advance drug development and evaluation processes of generic and new medicines.

CDER’s Office of Generic Drugs is developing a new data and text analysis tool, called Bioequivalence Assessment Mate (BEAM), to address the need for more efficient, consistent and high-quality bioequivalence assessments — or review and approval of generic drugs.

FDA considers two drugs to be bioequivalent when « the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. »…