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Table 15 Toolkit developed by HAI-AP to identify irrational FDCs

From: Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study

Requirements Scenario 1 Scenario 2 Scenario 3 Scenario 4 Scenario 5
Rationale for the combination Not usually Not usually ✓ ✓ ✓
Balancing advantages and disadvantages of the combination Not usually Not usually ✓ ✓ ✓
Marketing status in other countries ✓ ✓ ✓ ✓ ✓
Analysis of literature data in the submission Possibly for pharmaceutical development Possibly for pharmaceutical development ✓ ✓ ✓
Pharmaceutical development studies ✓ ✓ ✓ ✓ ✓
Good Manufacturing Practice (GMP) certification of sites of manufacture ✓ ✓ ✓ ✓ ✓
A full quality data set ✓ ✓ ✓ ✓ ✓
Bioavailability data Not usually Not usually Sometimes ✓ ✓
Bioequivalence data ✓ ✓ Sometimes Sometimes ✓
Preclinical pharmacology and safety Not usually Not usually Sometimes ✓ ✓
Clinical safety and efficacy Not usually Not usually ✓ ✓ ✓
Product information ✓ ✓ ✓ ✓ ✓
Plan for passive post marketing surveillance ✓ ✓ ✓ ✓ ✓
Plan for active post marketing surveillance Not usually Not usually ✓ ✓ ✓
Assurances ✓ ✓ ✓ ✓ ✓
  1. ✓ This is a requirement
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Global Health Research and Policy

ISSN: 2397-0642

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