The FDA has introduced a draft guidance document titled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This document outlines a framework to ensure the highest data integrity standards within clinical and bioanalytical areas.
Ensuring data integrity is crucial for supporting different drug applications, such as Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA). This guidance recommends applicants and testing site management to maintain data integrity in clinical and bioanalytical aspects of bioavailability (BA) and bioequivalence (BE) studies submitted for regulatory approval.
Additionally, it guides maintaining data integrity in the bioanalytical aspects of clinical pharmacologic studies that support biologic license applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), along with any amendments or supplements to these applications.
Moreover, this guidance extends its recommendations to cover the bioanalytical component of nonclinical studies. The FDA encourages applicants and testing sites to apply these recommendations across various study types, including in vitro, pharmacology, and toxicology studies.
The guidance provides recommendations for maintaining data integrity in three main areas: applicant actions, testing site management, and quality management system establishment. It emphasizes applicants’ accountability for identifying and implementing risk-based controls to ensure data integrity in their studies. While outlining fundamental principles, the guidance needs to list best practices exhaustively.
At Global Pharma Tek, we value the significance of the draft guidance, providing vital recommendations to applicants and testing site management. Our scientific and research team is committed to implementing robust quality management systems and safeguarding data integrity through world technology and tools across all Clinical Research stages and drug and device development trials.