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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