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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 about the role and about where the role is realized, appears, or occurs (through property "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"is played by" as well as the relationships "is manifested in" and "manifests" are inverse relationships respectively.

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

Example: Amlodpine

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Mesylate Monohydrate plays role active ingredient in

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Amlodipine EMC

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..g., the strength or further context specification (see below). 

If multiple roles needs need to be further grouped or if a role doesn't uniquely connect an object with a contextits manifestation, then the Pattern: Constituencies - DRAFT needs to be applied.

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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.

Diagram 2: The role class and its specialized sub-classes.

Everything below requires review/update

Optional Context Definition

The context is a "situation" or frame of reference in which something applies, exists, happens, or is used, and that helps to illustrate or explain it. As with roles, contexts can be further specified with sub-classes as shown in Diagram 3.

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Diagram 3:  

As for roles, "context can have subclasses to further specify its nature. 

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Context and its sub-classes.

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Amlodipine bezylate is used here as a simple example to demonstrate the modeling pattern for contextualized roles, where Amlodipine plays the active moiety role for the drug Amlodipine bezylate in a regulatory context.

Diagram 4: Modeling Amlodipine as the active moiety for Amlodipine bezylate in a regulatory context

Modeling

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the

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Modeling the different active moiety roles for Aripiprazole lauroxil in different contexts

Needs update see IDMP-514 : "Active Moiety for FDA Exclusivity" . TBD: Can we model this better as a role subclass?

The contextualized role pattern is used here to model interpretations of the active moiety role for Aripiprazole in different situations. Aristada is a drug developed by Alkermes and is composed of Aripiprazole lauroxil. Aripiprazole lauroxil is first metabolized to N-hydroxymethyl aripiprazole, which is then further metabolized to Aripiprazole which exerts pharmaceutical effects in the body. From a regulatory perspective, Aripiprazole is thus the active moiety. However, based on the interpretation of a patent by the US court, based on the fillings by the owner of the intellectual property (IP) on Aripiprazole lauroxil, the active component is stated as the N-hydroxymethylated product instead. Diagrams 5 and 6 below demonstrate how in different contexts, the active moiety for Aripiprazole lauroxil can be either N-hydroxymethyl aripripazole or Aripiprazole itself.

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Moiety Role - N-hydroxymethyl aripiprazole - Patent Exclusivity

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Exclusivity

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Drawio
border true diagramName Moiety Role - Aripiprazole - FDA Patent Exclusivity - simplified simpleViewer false links auto tbstyle top diagramDisplayName N-hydroxymethyl aripiprazole as the active moiety for Aripiprazole lauroxil in a FDA patent exclusivity regulatory context lbox true diagramWidth 883 revision 3

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