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Presentation of BE data in a product dossier

Presentation of BE data in a product dossier. Drs. Jan Welink. Training workshop: Training of BE assessors, Kiev, October 2009. Data in a bioequivalence dossier. Data in a bioequivalence dossier. Ethics:. Independent Ethics committee Ethical conduct of study Subject information and consent.

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Presentation of BE data in a product dossier

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  1. Presentation of BE data in a product dossier Drs. Jan Welink Training workshop: Training of BE assessors, Kiev, October 2009

  2. Data in a bioequivalence dossier

  3. Data in a bioequivalence dossier Ethics: • Independent Ethics committee • Ethical conduct of study • Subject information and consent

  4. Data in a bioequivalence dossier Investigational plan: • Overall study design and plan • Discussion of study plan • Selection of study population • Inclusion/exclusion criteria • Removal of subjects

  5. Data in a bioequivalence dossier Investigational plan: • Treatments • Treatments administered • Identity of investigational products • Randomisation • Selection of dose, time of dosing, administration procedure • Blinding • Prior and concomitant therapy

  6. Data in a bioequivalence dossier Investigational plan: • Pharmacokinetic and safety variables • Pharmacokinetic and safety variables assessed • Appropriateness of measurements • Primary pharmacokinetic variables • Drug concentration measurements

  7. Data in a bioequivalence dossier Investigational plan: • Data quality assurance • Statistical methods and sample size • Changes in conduct of study or planned analysis Study subjects: • Disposition of subjects • Protocol deviations

  8. Data in a bioequivalence dossier Pharmacokinetic evaluation: • Data sets analysed • Measurements • Results and tabulation of data • Analysis of results • Statistical and analytical consideration • Dropouts/missing data • Interim analysis/data monitoring

  9. Data in a bioequivalence dossier Safety evaluation: • Adverse events • Clinical laboratory evaluation • Vital signs, physical findings, other safety related observations • Safety conclusions

  10. Data in a bioequivalence dossier Discussion and conclusions. Tables, figures, graphs: • Demographic data • Pharmacokinetic data • Safety data

  11. Data in a bioequivalence dossier Appendices: • Study protocol, informed consent • Approval Independent Ethics committee • Details investigational products (CoA) • Randomisation scheme • Audit certificates • Documentation statistical methods

  12. Data in a bioequivalence dossier Appendices: • Bioanalytical method validation/analytical report subject sample analysis/chromatograms • Subject data listing • Case report forms

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