New FDA draft guidance for in vivo bioavailability and bioequivalence studies

The US Food and Drug Administration (FDA) yesterday published the draft guidance for industry, “ Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.”

This draft guidance provides recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applications, new drug applications, and abbreviated new drug applications, and the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated biologic license applications, as well as amendments and supplements to these applications.

The FDA expects that all data submitted to the agency are accurate, complete, and reliable, and that applicants and testing sites achieve and maintain data integrity throughout the data lifecycle of the product(s) or biologic therapeutic(s). This guidance provides recommendations to achieve and maintain data integrity with respect to applicants, testing site management, and implementation and management of a quality management system.