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Scientists Advancing Affordable Medicines

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    • 2022 Spring Scientific Workshop
    • 2019 Fall Scientific Workshop
    • 2019 Spring Scientific Workshop
    • 2018 Annual Scientific Workshop
  • Past Webinars
    • Data Integrity in Bioequivalence Studies
    • Challenges and Issues in Meeting Regulatory Requirements for In Vitro Dissolution TestingĀ 
    • Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development
    • In Silico Modeling Methods for Generic Drug Products: Applications and Expectations
    • 505(b)(2) Webinar Series: Session 3
    • 505(b)(2) Webinar Series: Session 2
    • 505(b)(2) Webinar Series: Session 1
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Data Integrity in Bioequivalence Studies

Industry and regulatory personnel from FDA presented on two important topics related to data integrity in bioequivalence study. The first session (June 11, 2024) covered the important aspect of ensuring data integrity in bioequivalence studies with the use of appropriate blinding to prevent bias. The speakers in this session discussed blinding requirements and strategies for a variety of different product types, including inhalation products, topical products, and others, as well as various study types, including in vitro, pharmacokinetic, pharmacodynamic, and clinical endpoint bioequivalence studies. The second session (June 13, 2024) focused on the various types of data manipulation that have been found in bioequivalence studies, the wide-ranging consequences that ensue when such data manipulation is detected, the efforts of regulatory agencies to screen for evidence of such data manipulation, and how sponsors can protect themselves. This session also addressed the issue of inadvertent sample swaps during the processing of blood samples into plasma/serum samples during the clinical phase of a pharmacokinetic study, and how such inadvertent swaps can be confirmed unambiguously to justify correction in the dataset.

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