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Merge pull request #550 from edmcouncil/IDMP-383
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IDMP-383 - ISO11615: Document the ISO IDMP conformance level as annotations in the IDMP-O where deviations exist
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@mereolog
mereolog authored Jan 4, 2024
2 parents 11885aa + 7688c34 commit 0f4f114
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35 changes: 29 additions & 6 deletions ISO/ISO11238-Substances.rdf
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<rdfs:subClassOf rdf:resource="&idmp-sub;SubstanceRole"/>
<rdfs:label>active ingredient</rdfs:label>
<skos:definition>ingredient present in a currently or previously marketed drug product indicating that it is or becomes pharmacologically active once delivered to patients</skos:definition>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
<cmns-av:adaptedFrom>Inxight Drugs, National Center for Advancing Translational Sciences, National Institutes of Health, derived from Definitions, available at https://drugs.ncats.io/about</cmns-av:adaptedFrom>
<cmns-av:synonym>active pharmacological ingredient</cmns-av:synonym>
</owl:Class>
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<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of an inactive ingredient that is any additive in the product</skos:definition>
<skos:note>Use only when there is no described pharmacological action and classification as merely &apos;inactive&apos; ingredient is not appropriate.</skos:note>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;Adjuvant">
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<rdfs:seeAlso rdf:resource="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C2140"/>
<skos:definition>ingredient that potentiates the immune response to an antigen and/or modulates it towards the desired immune response</skos:definition>
<skos:note>An adjuvant is an agent that enhances the activity or therapeutic effect of another pharmacologic substance without having much, if any, therapeutic impact by itself.</skos:note>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NamingConformant"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
<cmns-av:explanatoryNote>An adjuvant is defined as a component of a mixture in the ISO 11238 standard rather than as a role that such a component (substance) plays, thus this definition is non-conformant. It does, however, conform with its use as an ingredient in ISO 11615/TS 20443.</cmns-av:explanatoryNote>
</owl:Class>

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<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of an inactive ingredient that is the base of a preparation</skos:definition>
<skos:example>water, vaseline, ethanol</skos:example>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;ChemicalElement">
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<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of an inactive ingredient added to alter the color appearance</skos:definition>
<skos:prefLabel xml:lang="en-US">color ingredient</skos:prefLabel>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;ConformanceLevel">
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<rdfs:label xml:lang="en-US">contaminant ingredient</rdfs:label>
<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of an inactive ingredient whose presence is not intended but may not be reasonably avoided given the circumstances of the mixture&apos;s nature or origin</skos:definition>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;CopolymerConnectivity">
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<rdfs:label>excipient</rdfs:label>
<dct:source>Chemical Entities of Biological Interest Ontology, see http://purl.obolibrary.org/obo/CHEBI_75324</dct:source>
<skos:definition>pharmacological role of a generally pharmacologically inactive substance that is formulated with the active ingredient of a medication</skos:definition>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-DefinitionallyConformant"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-Extension"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
<cmns-av:explanatoryNote>An excipient is not explicitly defined in the ISO 11238 standard (although clause 8.5 states that an excipient is a non-active ingredient intended to be used in the medicinal product), which this definition conforms with although it is modeled as a role in this ontology.</cmns-av:explanatoryNote>
<cmns-av:synonym>bulking agent</cmns-av:synonym>
<cmns-av:synonym>filler</cmns-av:synonym>
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<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of an inactive ingredient added to alter the taste of the product</skos:definition>
<skos:prefLabel xml:lang="en-US">flavor ingredient</skos:prefLabel>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;Gene">
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<rdfs:subClassOf rdf:resource="&idmp-sub;SubstanceRole"/>
<rdfs:label>inactive ingredient</rdfs:label>
<skos:definition>ingredient of a given formulation (most frequently, an excipient) that does not exhibit pharmacological activity</skos:definition>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-Extension"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
<cmns-av:adaptedFrom>Inxight Drugs, National Center for Advancing Translational Sciences, National Institutes of Health, derived from Definitions, available at https://drugs.ncats.io/about</cmns-av:adaptedFrom>
<cmns-av:explanatoryNote>Substances are classified based on their effect on disease progression for a specific disease or condition. In this case, a condition is only related to such compound via the formulation used to affect (treat or diagnose) this condition.</cmns-av:explanatoryNote>
</owl:Class>
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<rdfs:label>ingredient</rdfs:label>
<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of a substance that is specifically part of or used in the preparation of some manufactured item, pharmaceutical product, medication, or drug</skos:definition>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NamingConformant"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
<cmns-av:synonym>pharmacological role</cmns-av:synonym>
<cmns-av:usageNote>An ingredient is defined as a material in the ISO 11238 standard rather than as a role, which would make the model inconsistent. Thus this concept is consistent in terms of its name but not in terms of its definition.</cmns-av:usageNote>
<cmns-av:usageNote>Note that any inactive ingredient that is described as &apos;ingredient not otherwise specified&apos; in the ISO/TS 20443 implementation guide will simply be classified as an ingredient at this level in the hierarchy in the ontology, or as an inactive ingredient without other differentiation.</cmns-av:usageNote>
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<rdfs:label>manufacturer</rdfs:label>
<skos:definition>functional role of a party that produces finished products from raw materials or components using tools, machinery, labor, and chemical or physical transformation</skos:definition>
<skos:note>In the context of ISO 11238, the definition refers to a company responsible for the manufacturing of the substance. From a more general ISO IDMP perspective, a manufacturer refers to an organization that holds the authorization for the manufacturing process.</skos:note>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-ModelConformant"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NonConformant"/>
<cmns-av:adaptedFrom>ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.39</cmns-av:adaptedFrom>
<cmns-av:synonym>establishment</cmns-av:synonym>
</owl:Class>
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<skos:definition>role of an inactive ingredient which, as a whole, lends a spatial structure to the product, which structure is meaningful to the delivery of the pharmacologically active ingredients near the target site</skos:definition>
<skos:example>For example, a collagen matrix used as a base for transplanting skin cells.</skos:example>
<skos:note>Such ingredient has a function other than merely delivering the pharmacologically active substances into a systemic compartment (such as, for example, an ordinary capsule would have.)</skos:note>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;Mixture">
Expand Down Expand Up @@ -3636,6 +3642,7 @@ For the description of nucleic acids, the following information can be used to a
<rdfs:label xml:lang="en-US">preservative ingredient</rdfs:label>
<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of an inactive ingredient added to delay the risk of the product&apos;s spoiling</skos:definition>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;ProcessingMaterialRole">
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<rdfs:label xml:lang="en-US">stabilizer ingredient</rdfs:label>
<dct:source>ISO/TS 20443:2017(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, table D.1, clause D.2.1</dct:source>
<skos:definition>role of an inactive ingredient added to to keep the mixture homogenic (e.g. prevent the phases of an emulsion to separate)</skos:definition>
<skos:prefLabel xml:lang="en-GB">stabiliser ingredient</skos:prefLabel>
<skos:prefLabel xml:lang="en-US">stabilizer ingredient</skos:prefLabel>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-NameAndAnnotationConformant"/>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;StartingMaterialRole">
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<cmns-av:directSource>ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.4</cmns-av:directSource>
</owl:DatatypeProperty>

<owl:DatatypeProperty rdf:about="&idmp-sub;hasEffectiveDate">
<rdfs:subPropertyOf rdf:resource="&cmns-dt;hasDateValue"/>
<rdfs:label>has effective date</rdfs:label>
<rdfs:range rdf:resource="&xsd;string"/>
<skos:definition>indicates the date on which something, such as an event, substance, or product, takes place or is effective</skos:definition>
<skos:example>20110219</skos:example>
<skos:note>The date when the substance was effective should be provided in line with the ISO 8601 date format. This shall be defined when the substance is generated or modified.</skos:note>
<idmp-sub:hasBusinessRules>The value may be implicitly derived.</idmp-sub:hasBusinessRules>
<idmp-sub:hasConformanceLevel rdf:resource="&idmp-sub;ConformanceLevel-Mandatory"/>
<idmp-dtp:isEncodedAs rdf:resource="&idmp-dtp;DatatypeCode-TS"/>
<cmns-av:adaptedFrom>ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.12.2</cmns-av:adaptedFrom>
<cmns-av:usageNote>The effective date is mandatory from a version perspective in ISO 11238, but may be optional or conditional when used in conjuction with other concepts.</cmns-av:usageNote>
</owl:DatatypeProperty>

<owl:ObjectProperty rdf:about="&idmp-sub;hasFivePrimeSubstanceIdentifier">
<rdfs:subPropertyOf rdf:resource="&idmp-sub;hasRelatedSubstanceIdentifier"/>
<rdfs:label>has five prime substance identifier</rdfs:label>
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