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On May 15, 2024, the Health Care Law Today publication discussed the importance of maintaining data integrity in bioavailability and bioequivalence studies conducted in vivo. This topic is particularly relevant due to previous instances of data integrity issues that have arisen in the field.

In response to these concerns, the U.S. Food and Drug Administration released a draft guidance in April 2024. This guidance is aimed at providing recommendations to applicants and testing site management on how to achieve and uphold data integrity for the clinical and bioanalytical aspects of bioavailability and bioequivalence studies.

The draft guidance outlines key considerations for maintaining data integrity in studies submitted in support of investigational new drug applications, new drug applications, and abbreviated new drug applications. By following these recommendations, stakeholders in the field can ensure that the data generated from these studies is accurate, reliable, and trustworthy.

Overall, the draft guidance serves as a valuable resource for those involved in bioavailability and bioequivalence studies. It offers practical advice on how to prevent data integrity issues and maintain the quality and credibility of the data collected during these important research endeavors. By adhering to these guidelines, stakeholders can contribute to the advancement of medical science and the development of safe and effective pharmaceutical products.