Drugs

Bioavailability/Bioequivalence Data Integrity Guide

FDA has released a draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” that provides recommendations to applicants and testing site management on maintaining data integrity for drug-related clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted to CDER. The recommendations in the guidance are primarily focused on electronic data, but they can also be applied to other data types and formats.

The agency says it is each applicant’s “responsibility to achieve and maintain data integrity for their studies, which includes identifying and implementing the most effective and efficient risk-based controls.” The document says data integrity applies to the “accuracy, completeness, and reliability of data. Accurate, complete, and reliable data should be attributable to the person generating the data, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).” The guidance also distinguishes data integrity from data quality. “For purposes of this guidance,” it says, “data quality refers to the assurance that data produced are generated in compliance with applicable standards and can be used for its intended purpose.”

FDA says that in recent years, it has cited data integrity concerns during the inspection of testing sites, clinical testing sites, and analytical testing sites, and during the assessment of the BA and BE study data submitted in support of applications. “Data integrity concerns can impact application acceptance for filing, assessment, regulatory actions, and approval as well as post-approval actions, such as therapeutic equivalence ratings,” it says. “It is the role of industry, specifically management with executive responsibility, to create a quality culture where personnel understand that data integrity is an organizational core value and personnel are encouraged to identify and promptly report data integrity issues. In the absence of management support of a quality culture, systems can break down and lead to errors and misconduct.”

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