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Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

 
• By Sue Sutter

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

Drawing bullseye
A new guidance takes aim at the data integrity problems that have plagued industry in recent years. • Source: Shutterstock

A new US Food and Drug Administration guidance takes aim at heading off a high-profile problem that has troubled the generic drug industry in recent years – fraud and other data integrity issues with bioavailability and bioequivalence studies.

Recommendations in the draft guidance, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies,” are aimed at addressing the types of data integrity concerns the agency has seen during...

Key Takeaways

  • FDA’s new draft guidance is aimed at heading off the types of data integrity concerns with BA/BE studies seen during inspections and drug application assessments.

    • ...

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