Zdrowie i gospodarka · 11/07/2002

Draft Revised Guidance for Industry on Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry entitled "Bioavailability and Bioequivalence for Orally Administered Drug Products--General Considerations." FDA's Biopharmaceutics Coordinating Committee determined that a revision of the guidance was necessary as a result of experience with implementation of the guidance, input from the Advisory Committee for Pharmaceutical Science at a meeting held on November 28 and 29, 2001, and changes in agency thinking based on new data. This revision should provide better guidance to sponsors conducting bioavailability (BA) and bioequivalence (BE) studies for orally administered drug products.