D2S08-Ren-v1.2-FINAL.pdf

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1、Data Integrity and Data Quality Issues in Abbreviated New Drug ApplicationsKe Ren,Ph.D.Deputy Division DirectorDivision of Bioequivalence III,Office of BioequivalenceOffice of Generic Drugs|CDER|US FDAApril 23,20262Disclaimer:This presentation reflects the views of the presenter and should not be co

2、nstrued to represent FDAs views or policies.3Learning Objectives3Provide the fundamental principles of data integrity in Abbreviated New Drug Applications(ANDAs)Recognize the roles and responsibilities of sponsors,investigators,and Contact Research Organizations(CROs)in maintaining data integrity th

3、roughout the study lifecycleHighlight case studies,identify common data anomalies,and integrity issues Comprehend FDAs regulatory response to data integrity violations4Data Integrity DefinitionAttributable-Clearly linked to the person who generated itLegible-Readable and understandableContemporaneou

4、s-Recorded at the time the activity was performedOriginal-The first recording,or a true verified copyAccurate-Free from errors and truthfulAALOCData integrity refers to the accuracy,completeness,and reliability of the data throughout its lifecycle.The ALOCA principles should be followed:Ensuring dat

5、a integrity is fundamental to maintaining quality,compliance,and trust in the regulatory process.Draft FDA Guidance for Industry:Data Integrity for In Vivo Bioavailability and Bioequivalence Studies(https:/www.fda.gov/media/177404/download,April 2024)5Data Integrity:Foundation for Regulatory Decisio

6、n-Making and Public Health ProtectionWhy Data Integrity MattersConsequences of Poor Data Quality Ensure the safety,efficacy and quality of drug product Supports the FDAs ability to evaluate drug applications and protect public health Represents a key responsibility of pharmaceutical companies and CR