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Table of Contents

Ontology Development

Summary

  1. In Q1 2024 there were two primary areas of work, including:
    significant additions to cover details needed for representation of biologics – organisms, parts of organisms, the subset of the Linnean taxonomy needed for herbal substances, inheritance relationships between organisms, completion of the model with respect to target and target interaction, and related areas in the ISO 11238 Substance ontology, and
  2. significant additions to cover gaps in the ISO 11615 model related to medicinal products, package items and other concepts required for the jurisdiction-agnostic UC4 – adding concepts representing attributes and relations that were not completely modeled for therapeutic indications, contraindications, and population characteristics; completing the definition of pharmaceutical product characteristic, completing details for manufactured item and package item, completing details related to pharmaceutical dose form and its subclasses (administrable, combined), and related restrictions on medicinal product, and adding missing attributes and relations such as ‘special measures’, pediatric use indicator, and monitoring indicator, as well as addressing other miscellaneous gaps and issues in restrictions in that part of the ontology for ISO 11615.

Quantitative View

Three ontologies were deleted:

  1. frbr
  2. c4o
  3. datacite

The following ontologies were revised and/or extended:


OntologiesDeleted ResourcesNew ResourcesModified Resources
AmlodipineExample002
deo160
doco161337
DocumentComponents008
ISO1087-TerminologyScience001
ISO1087-VocabularyForTermsAndDefinitions002
ISO11238-Substances25344
ISO11615-MedicinalProducts11750
ISO21090-HarmonizedDatatypes203
MedicalDictionaryForRegulatoryActivities001
Organizations008
po31300
ProductsAndServices004
QlairaExample684
QuantitiesAndUnits0218
RegistrationAuthorities003
RegulatoryAgencies002
StatisticalMeasures003
SubstancesProductsOrganisationsReferentials001

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