1. U.S. Food & Drug Administration Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Ū General Considerations https://www.fda.gov/ohrms/dockets/ac/03/briefing/3995B1_07_GFI-BioAvail-BioEquiv.pdf. 2003
2. U.S. Food & Drug Administration Guidance for Industry (Draft): Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377465.pdf 2013