What is a bioavailability & bioequivalence guidance?
The draft guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.
What are the guidelines for a single-dose in vivo bioavailability or bioequivalence study?
§ 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study. ( a) Basic principles. ( 1) An in vivo bioavailability or bioequivalence study should be a single-dose comparison of the drug product to be tested and the appropriate reference material conducted in normal adults.
What are the requirements for a bioequivalence study?
( 1) Evidence demonstrating that the drug product that is the subject of the abbreviated new drug application is bioequivalent to the reference listed drug (defined in § 314.3 (b) of this chapter ). A complete study report must be submitted for the bioequivalence study upon which the applicant relies for approval.
What is a BA study & a bioequivalence study?
The guidance provides recommendations on conducting BA studies during the investigational period for a drug intended to be submitted for approval in an NDA and bioequivalence (BE) studies during the postapproval period for certain changes to drug products with an approved NDA.
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