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Table 13 Application of toolkit to assess the rationality of fixed-dose drug combinations obtained from Pokhara (n = 4)
| Criteria | FDCs* | |||
|---|---|---|---|---|
| A | B | C | D | |
| Rationale for the combination | ✓ | ✓ | ✓ | ✓ |
| Balancing advantages and disadvantages of the combination | X | X | X | X |
| Marketing status in other countries | ✓ | ✓ | ✓ | ✓ |
| Analysis of literature data in the submission | X | X | X | X |
| Pharmaceutical development studies | X | X | X | X |
| Good Manufacturing Practice (GMP) certification of sites of manufacture | X | X | X | X |
| A full quality data set | X | X | X | X |
| Bioavailability data | - | - | X | - |
| Bioequivalence data | - | - | X | - |
| Preclinical pharmacology and safety | - | - | X | - |
| Clinical safety and efficacy | X | X | X | X |
| Product information | ✓ | ✓ | ✓ | ✓ |
| Plan for passive post marketing surveillance | X | X | X | X |
| Plan for active post marketing surveillance | X | X | X | X |
| Assurances | X | X | X | X |
