Current Evaluation Process

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Presentation transcript:

Current Evaluation Process Sponsor BPA CDE Bridging data package Summary of self-evaluation Checklist Case registered Internal review meeting Consultants If needed Supplemental documents If needed sponsor meeting Bridging Study waived Drug Advisory committee Bridging Study required

“Working Lists” PK/PD Properties and Clinical Properties for Assessing Ethnic Sensitivity -- PK/PD 1. Is there a non-linear pharmacokinetics? 2. Is there a steep pharmacodynamic curve for both efficacy and safety in the range of the recommended dosage and dose regimen ? 3. Is the therapeutic dose range narrow ? 4. Is it highly metabolized, especially through a single pathway ? 5. Is it metabolized by enzymes known to be genetically polymorphic ? 6. Is it administered as a prodrug ? 7. Dose it show high inter-subject variation in bioavailability ? 8. Is it low in bioavailability ?

“Working Lists” PK/PD Properties and Clinical Properties for Assessing Ethnic Sensitivity -- Clinical Is it likely to be used in a setting of multiple co- medications ? 10. Is it prone to be used inappropriately? 11. Is there any epidemiologic difference concerning the indication between the reference population and ours ? 12. Other important ethnic sensitive factors ?

Checklist Checklist for the Evaluation of Bridging Study by the Sponsor Info provided Reference Y N Vo1./Page I. The current worldwide regulatory status of the drug II. NDA expert report or Investigator’s Brochure III. Pharmacokinetics, safety and efficacy data of Asian Population IV. Comparison of the above data with those of other population V. Self evaluation VI. Post-marketing surveillance data VII. Overall conclusion

Checklist V.Self evaluation Y N U Info Provided Reference Y N Vo1./Page 1. Is there a non-linear pharmacokinetics? 2. Is there a steep pharmacodynamic curve for both efficacy and safety in the range of the recommended dosage and dose regimen ? 3. Is the therapeutic dose range narrow ? 4. Is it highly metabolized, especially through a single pathway ? 5. Is it metabolized by enzymes known to be genetically polymorphic ? 6. Is it administered as a prodrug ?

Checklist V.Self evaluation Y N U Info Provided Reference Y N Vo1./Page 7. Dose it show high inter-subject variation in bioavailability ? 8. Is it low in bioavailability ? 9. Is it likely to be used in a setting of multiple co-medications ? 10. Is it prone to be used inappropriately? 11. Is there any epidemiologic difference concerning the indication between the reference population and ours ? 12. Other important ethnic sensitive factors ?