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Table 11 Application of toolkit to assess the rationality of fixed-dose drug combinations obtained from Birgunj (n = 11)

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

Criteria FDCs*
A B C D E F G H I J K
Rationale for the combination
Balancing advantages and disadvantages of the combination X X X X X X X X X X X
Marketing status in other countries
Analysis of literature data in the submission X X X X X X X X X X X
Pharmaceutical development studies X X X X X X X X X X X
Good Manufacturing Practice (GMP) certification of sites of manufacture X X X X X X X X X X X
A full quality data set X X X X X X X X X X X
Bioavailability data X - - - - X X X - - X
Bioequivalence data X - - - - - X X - - X
Preclinical pharmacology and safety X - - - - X X X - - X
Clinical safety and efficacy X X X X X X X X X X X
Product information
Plan for passive post marketing surveillance X X X X X X X X X X X
Plan for active post marketing surveillance X X X X X X X X X X X
Assurances X X X X X X X X X X X
  1. ’ = Fulfilled, ‘X’ = Not fulfilled, ‘-’ = Not required * = refer to Table 2