ABSTRACT
To receive approval for an abbreviated new drug application (ANDA), an applicant generally must demonstrate, among other things, that its 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 (RLD) (21 U.S.C. 355(j)(2)(A); 21 CFR 314.94(a)). Bioequivalent drug products show no signicant difference in the rate and extent of absorption of the therapeutic ingredient (21 U.S.C. 355(j)(8); 21 CFR 320.1(e)). Bioequivalence (BE) studies are undertaken in support of ANDA submissions with the goal of demonstrating BE between a proposed generic drug product and its RLD. The regulations governing BE are provided at 21 CFR in part 320. The U.S. Food and Drug Administration (FDA) has recently begun to promulgate individual BE requirements. To streamline the process for making guidance available to the public on how to design productspecic BE studies, the U.S. FDA will be issuing product-specic BE recommendations (www.fda.gov/ cder/ogd/index.htm). Given later are the current recommendations for more signicant products.
