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

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  and bioequivalence studies submitted in support of investigational new drug applications, new drug applications (NDAs), and abbreviated new drug applications, and the bioanalytical portion of clinical pharmacologic studies supporting -regulated biologic license applications as well as amendments and supplements to these applications.