Draft Guidance for Industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System.'' When final, the guidance will provide recommendations to sponsors of investigational new drug applications (IND's) and applicants submitting new drug applications (NDA's), and abbreviated new drug applications (ANDA's) who intend to perform bioavailability and bioequivalence (BA/ BE) studies for immediate release solid oral products during either the preapproval or postapproval periods.