Guidance for Industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System." The guidance provides recommendations to sponsors of investigational new drug applications (IND's), new drug applications (NDA's), abbreviated new drug applications (ANDA's), and supplements to these applications who wish to request a waiver of in vivo bioavailability (BA) and bioequivalence (BE) studies for immediate-release solid oral dosage forms.