1. 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

2. “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 ?

3. “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 ?

4. 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

5. 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 ?

6. 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 ?