Details

Titel

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

Ist Teil von

• The Federal Register / FIND, 2017, Vol.82 (246), p.61011

Ort / Verlag

Washington: Federal Information & News Dispatch, LLC

Erscheinungsjahr

2017

Link zum Volltext

Quelle

BSC - Ebsco (Business Source Ultimate)

Beschreibungen/Notizen

• Notice of availability. Citation: "82 FR 61011" Document Number: "Docket No. FDA-2015-D-1245" Page Number: "61011" "Notices" SUMMARY: The Food and Drug Administration (FDA or Agency) 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." This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.