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Table 14 Application of toolkit to assess the rationality of fixed-dose drug combinations obtained from Kathmandu (n = 4)

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

Criteria FDCs*
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 - - - -
Bioequivalence data - - - -
Preclinical pharmacology and safety - - - -
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
  1. ’ = Fulfilled, ‘X’ = Not fulfilled, ‘-’ = Not required * = refer to Table 5