Add to ChromeRhizome evaluates bioequivalence of generic drug applications using regulatory, scientific, and statistical criteria to ensure comparable performance to the reference listed drug.
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The Center for Drug Evaluation and Research (CDER) assesses bioequivalence (BE) in generic drug applications primarily through a combination of regulatory requirements, scientific guidelines, and statistical criteria. The process ensures that a generic drug performs in the same manner as its reference listed drug (RLD).
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