1. Introduction into the workshop Drs. Jan Welink Training workshop: Training of BE assessors, Kiev, October 2009

2. 2 |2 | Template for case studies Two assessment forms: Example of assessment report BE study Example of a template for assessment of a BE study retrieved from EU template

3. Training workshop: Training of BE assessors, Kiev, October 2009 3 |3 | Template for case studies Use of template: to be filled in by assessors/regulator differs from WHO template!!

4. Training workshop: Training of BE assessors, Kiev, October 2009 4 |4 | Template for case studies Clinical study reports: GCP aspects –audits, inspections, known CRO Biowaiver –for which strengths, which information submitted, acceptability

5. Training workshop: Training of BE assessors, Kiev, October 2009 5 |5 | Template for case studies Pharmacokinetic studies: Study design IEC approval Study dates BE study and analysis CRO/study centres

6. Training workshop: Training of BE assessors, Kiev, October 2009 6 |6 | Template for case studies Test and Reference product: Test (biobatch) product: –manufacturer, manufacturing date, expire date –batch size, potency Reference product: –MAH, origin –batch number, expire date, potency

7. Training workshop: Training of BE assessors, Kiev, October 2009 7 |7 | Template for case studies Study population: Demographic data Number included Number excluded

8. Training workshop: Training of BE assessors, Kiev, October 2009 8 |8 | Template for case studies Analytical methods: Validation –short description –calibration curve range/LoQ –accuracy and precision values –stability data Analysis subject samples –precision and accuracy –reanalysis –storage period –chromatograms

9. Training workshop: Training of BE assessors, Kiev, October 2009 9 |9 | Template for case studies Pharmacokinetic variables: short method description Statistical method: short description factors included declaration of bioequivalence

10. Training workshop: Training of BE assessors, Kiev, October 2009 10 | Template for case studies Results: PK data (mean/sd) –pre-dose values –extent of absorption (>80%) –Cmax in first sampling point?? –mean C-t curve Statistical outcome –Geometric means, ratio, 90% CI –ANOVA CV% Conclusion: Objections/concerns

11. Training workshop: Training of BE assessors, Kiev, October 2009 11 | Template for case studies