Introduction

Ontologies are a representation of domain knowledge using defined concepts and the relationships between those concepts in a manner understandable to both humans and machines.

With the IDMP Ontology, we can express statements about things such as substances or medicinal products. While some statements are universally true (e.g., "Amlodipine is a chemical substance" or "Amlodipine is included in Norvasc") others , some statements are true only in specific situations/contexts, e.g., the " strength of Amlidipine" a certain substance makes sense only in the context of a product.

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The role concept (hereafter referred to as 'role') and corresponding ontological role model pattern provide a structured and modular way to capture many different real-world complexities.

Related Competency Questions

• What is the active moiety of <SUBSTANCE>?
• What is the investigational/authorized medicinal product in <CLINICAL TRIAL>?

Relation to ISO-IDMP Standards

There is no general role pattern described in the ISO IDMP standards. However, roles are mentioned, e.g., for describing an ingredient in the context of a pharmaceutical product. See also Pattern: Ingredient - DRAFT

Modeling Pattern

In the following, we incrementally explain why we need roles, how contextualized roles are modeled in general and instantiated with examples.

Universal Statement (NO Role usage)

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In order to further specify a relationship, we use the basic role pattern that allows us to provide details that are valid only in a certain context in which the role "is manifested in".

The relationships between the object that plays the role and the context in which it is manifested are pairs of inverse relationships respecitively.

Of course these general classes "Thing" and "Role" are instantiated with more specific subclasses as illustrated in the next example:

Example: Amlodpine Besylate plays role active ingredient in Norvasc

The important thing is that we can now attach all information that further specifies the role of Amlodipine mesylate monohydrate in the context of Amlodipine EMC to the middle role node in the graph, e. E.g., the strength.

Roles and Constituents (Product Compositions)

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