Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

The roles identified above extend the ingredient class, with the codes expressed as a controlled vocabulary with code elements mapped to them. Figure 2, below, shows how the codes map to some of the roles, and how the model for ingredient corresponds to Figure 12 from the IDMP standard. Each of the roles specified in the IDMP standard will be subclasses of ingredient, signified by the proper code, and additional semantics for those roles, such as the connections to reference substances can be modeled directly for those roles that require that link in the graph. Elements in white are classes in the ontology. Elements in blue are instances, in this case, of codes.

Drawio
bordertrue
diagramNameingredient roles expanded
simpleViewerfalse
linksauto
tbstyletop
lboxtrue
diagramWidth919
revision8

...

This becomes more complicated when defining the notion of a substance as an active ingredient in a given product, as in some cases the strength is required, and in others, a reference strength may be required. See Pattern: Representing Reference Substances, Reference Strength, and the Basis of Strength, including in Different Jurisdictions - REVIEWAPPROVED for further refinement with respect to modeling the basis of strength in the context of a given pharmaceutical product that is authorized for marketing or investigational use in a specific jurisdiction.

...

Figure 4, below, provides a partial example (with some details elided) of the representation of a chemical substance as an active ingredient with its strength. This example is also encoded in the set of examples provided with the ontology. Note that the elements in white are classes in the ontology. Elements in blue are instances of those classes, and in purple are literal values.

Drawio
bordertrue
diagramNamestrength depiction
simpleViewerfalse
linksauto
tbstyletop
lboxtrue
diagramWidth1279
revision910

Figure 4. Example partial diagram for the substance amlodipine besylate as an active ingredient of the product NorvascĀ 

Note that this pattern does not cover complexities such as the basis of strength, which are addressed in more detail on Pattern: Representing Reference Substances, Reference Strength, and the Basis of Strength, including in Different Jurisdictions - REVIEWAPPROVED. These complexities require more complete coverage of the relationships between a product and its constituents in the context of a specific marketing authorization in a given jurisdiction.

...