...

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. However, this knowledge representation usually expresses a narrow, ideal situation, which might not reflect real-world complexities. Contextualization of the

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") others are true only in specific situations/contexts. To capture the context a common pattern in ontology modelling is to use "roles". E.g., a human Max can play the role "patient" in the context of a treatment. Or a substance can play the role "active ingredient" in the context of one pharmaceutical product while the same substance may play the role "excipient" in the context of a different product.

The role concept (hereafter referred to as 'role') and role modelling provides corresponding ontological role model pattern provide a structured and modular way to capture these many different real-world complexities. In order to model how different regulatory contexts can affect the definition of the active moiety role, the general pattern for contextualized roles as shown in diagram 1 is applied to the examples for Amlodipine and Aripiprazole below.

Heiner Oberkampf  provide intro for what are roles and why we need them

substance constituency - constituency that defines some substance based on its relationship(s) to some other substance (ingredient) or moiety, potentially in some amount, in some context

Li Ming Gooi Break down into three different diagrams

Basic Role Pattern

Example: Ingredient as a Substance Role

tbd

Roles and Constituents

substance constituency - constituency that defines some substance based on its relationship(s) to some other substance (ingredient) or moiety, potentially in some amount, in some context

Diagram 1: General pattern for contextualized roles.

Role Hierarchy in IDMP-O

The role (https://www.omg.org/spec/Commons/PartiesAndSituations/Role) is modeled as a class and can be specialized with sub-classes some of which are shown in diagram 2.

...