Download Checklist

Current Evaluation Process
Sponsor
• Bridging data package
• Summary of selfevaluation
BPA
Checklist
Consultants
CDE
Case registered
Internal review
meeting
If needed
Supplemental
documents
Bridging Study
waived
Bridging Study
required
If needed
Drug Advisory
committee
sponsor meeting
“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
9. Is it likely to be used in a setting of multiple comedications ?
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
Vo1./Page
N
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
Y
N
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 ?
• • •
•
•
Reference
Vo1./Page
Checklist
V.Self evaluation
Y
N
U
Info
Provided
Y
N
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 ?
• • •
•
•
Reference
Vo1./Page