Table 13 Application of toolkit to assess the rationality of fixed-dose drug combinations obtained from Pokhara (n = 4)

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