The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support investigational new drug application (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs), and certain biologic license applications (BLAs).
The guidance was developed by FDA’s Office of Generic Drugs (OGD), the Office of Study Integrity and Surveillance (OSIS) and the Office of Clinical Pharmacology (OCP) in the Office of Translational Sciences (OTS) in the Center for Drug Evaluation and Research (CDER). FDA defines data integrity as the “accuracy, completeness, and reliability of data.”…
