Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Handling and Retention of BA and BE Testing Samples." The guidance is intended to provide recommendations for study sponsors and/or drug manufacturers, contract research organizations, site management organizations, clinical investigators, and independent third parties on the procedure for handling reserve samples from bioavailability (BA) and bioequivalence (BE) studies. The guidance clarifies how to distribute test articles and reference standards to testing facilities, how to randomly select reserve samples, and how to retain reserve samples.