🔔 Note: Stop playback at 34:49 to complete this lesson.
Presenter
Li-Hong (Paul) Yeh, PhD
Interdisciplinary Scientist
Division of New Drug Study Integrity (DNDSI)
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This presentation, delivered by Dr. Li-Hong Yeh from the FDA’s Office of Study Integrity and Surveillance (OSIS), details analytical inspections for bioavailability/bioequivalence (BA/BE) studies. As a crucial part of the FDA’s Bioresearch Monitoring (BIMO) program within CDER, OSIS ensures the quality, integrity, and regulatory compliance of BA/BE study data, safeguarding human subjects and providing reliable information for regulatory decisions. The OSIS workflow encompasses site selection, conducting inspections, and reporting findings. Inspections are performed through both on-site evaluations and remote regulatory assessments (RRA), a tool adopted to continue oversight, particularly during the pandemic. The core focus of these analytical inspections includes method validations and the thorough analysis of study samples, scrutinizing aspects like system suitability, run acceptance, justified re-injections, internal standard variability, PK anomalies, and incurred sample reproducibility. Common issues identified include incomplete method validation, insufficient stability data, and inadequate documentation for study reconstruction. OSIS’s efforts are vital in ensuring that all data submitted to the FDA for drug products are complete, accurate, and reliable, thereby protecting public health.