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

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Presentation on theme: "Presentation of BE data in a product dossier Drs. Jan Welink Training workshop: Training of BE assessors, Kiev, October 2009."— Presentation transcript:

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

2 2 |2 | Data in a bioequivalence dossier

3 Training workshop: Training of BE assessors, Kiev, October |3 | Data in a bioequivalence dossier Ethics: Independent Ethics committee Ethical conduct of study Subject information and consent

4 Training workshop: Training of BE assessors, Kiev, October |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 Training workshop: Training of BE assessors, Kiev, October |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 Training workshop: Training of BE assessors, Kiev, October |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 Training workshop: Training of BE assessors, Kiev, October |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 Training workshop: Training of BE assessors, Kiev, October |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 Training workshop: Training of BE assessors, Kiev, October |9 | Data in a bioequivalence dossier Safety evaluation: Adverse events Clinical laboratory evaluation Vital signs, physical findings, other safety related observations Safety conclusions

10 Training workshop: Training of BE assessors, Kiev, October | Data in a bioequivalence dossier Discussion and conclusions. Demographic data Pharmacokinetic data Safety data Tables, figures, graphs:

11 Training workshop: Training of BE assessors, Kiev, October | 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 Training workshop: Training of BE assessors, Kiev, October | Data in a bioequivalence dossier Appendices: Bioanalytical method validation/analytical report subject sample analysis/chromatograms Subject data listing Case report forms

13 Training workshop: Training of BE assessors, Kiev, October |


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