USA – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies: Guidance for Industry

The FDA issued for comments a Draft guidance for Industry on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. The purpose of this guidance is to provide 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 (INDs), new drug applications (NDAs), and abbreviated new...