Release Notes 1.0.0

Release Notes 1.0.0

Ontology Development

Summary

The IDMP-O release 1.0 is the first production-ready version. It covers many different use cases around substance identification, medicinal products and pharmaceutical products.

Over the last quarter, since the 0.5.0 release, the development team has focused on:

  1. better coverage of the ISO 11238 Substances content.

  2. better coverage of the ISO 11615 Medicinal Products content.

  3. extending and improving examples to demonstrate how to use the ontologies in real-world applications.

We have also worked towards increased usability and flexibility, and augmented these two ontologies with additional metadata to improve understandability. Details, including additional references and the degree to which a given element complies with the ISO standard(s), were also added. 

In addition to adding new content, we have taken advantage of revisions to the OMG Commons Ontology Library v1.1 updates. Four additional ontologies have been added as formal standards at OMG, which are now dereferenceable from the OMG website. They include the Documents, Parties and Situations, Roles and Compositions, and Quantities and Units ontologies that IDMP-O depends on. We anticipate publication of another update to the Commons Library, including the other 5 ontologies that our main ISO standard ontologies depend on in mid-2024. See https://www.omg.org/spec/Commons/ for more information.

Also, in order to demonstrate how to extend labeling details as required by the ISO IDMP standards with tables or other rich document content, we've integrated a new family of ontologies from the library science community called the "SPAR Ontologies", or Semantic Publishing and Referencing Ontologies (see http://www.sparontologies.net/ and https://github.com/sparontologies for more information). These ontologies include a few issues which we are working with their development team to resolve, and are only used in examples as a consequence. Together with a new DocumentComponents ontology in IDMP, they address challenges for IDMP based regulatory reporting related to linking content embedded in documents, including rich tables, which are referenced as string values in the IDMP ISO documents. These are described under the quantitative view, below, among the 7 new ontologies listed. They are also described in examples at Pattern: Citing and linking into reference documents - REVIEW.

We removed one starting point example which may be reintegrated over the coming months if it is needed. It did not show enough new content to warrant integration in the 1.0 release.

Quantitative View

One ontology was deleted:

  1. CellCeptExample – incomplete example that may be added back later this year

7 new ontologies were added:

  1. c40 – Citation Counting and Context Characterisation Ontology (C4O)

  2. datacite – covers the DataCite Metadata Schema Specification for citations

  3. deo – Discourse Elements Ontology (DEO)

  4. doco – Document Components Ontology (DoCo)

  5. frbr – Essential FRBR in OWL2 DL Ontology (FRBR), which corresponds to the IFLA report on the Functional Requirements for Bibliographic Records (FRBR)

  6. po – Pattern Ontology (PO)

  7. DocumentComponents – an extension to the SPAR ontologies primarily focused on table content 

Except for the last one, all of them are SPAR ontologies.

The following ontologies were revised and/or extended:

Ontologies

Deleted Resources

New Resources

Modified Resources

Ontologies

Deleted Resources

New Resources

Modified Resources

AmlodipineExample

58

259

24

EuropeanRegulatoryAgencies

0

0

2

EuropeanUnionClinicalTrialsRegister

4

12

5

ISO11238-Substances

4

66

114

ISO1087-TerminologyScience

0

0

1

ISO1087-VocabularyForTermsAndDefinitions

0

0

2

ISO11238-RegistrationAuthorities

0

0

1

ISO11240-UnitsOfMeasurement

0

5



ISO11615-MedicinalProducts

2

78

84

ISO21090-HarmonizedDatatypes

0

0

14

MedicalDictionaryForRegulatoryActivities

0

0

5

Organizations

0

0

2

ProductsAndServices

0

0

4

QlairaExample

79

226

5

RegistrationAuthorities

0

0

3

RegistrationAuthorities

0

0

2

StatisticalMeasures

0

0

3

SubstancesProductsOrganisationsReferentials

6

1

69

TerlipressinExample

7

19

19

Detailed View

resources in 0.5.0 but not 1.0.0 release

Ontologies

Resources in 0.5.0 but not in 1.0.0

Ontologies

Resources in 0.5.0 but not in 1.0.0

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/TherapySpecification

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/InactiveIngredient

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineDenominatorInNorvascPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackageTablets

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Paperboard

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Norvasc-RouteOfAdministration

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateMolecularStructure

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateMolecularStructure

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Amlodipine

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Cardboard

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateMolecularFormulaByMoiety

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineAsReferenceStrengthInAmlodipineEMCStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Norvasc-ManufacturedItem

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/CardboardCommonName

AmlodipineExample

https://chem.nlm.nih.gov/chemidplus/rn/440358-84-9

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateSimplifiedMolecularInputLineEntry

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateNumeratorInNorvascPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineOfficialName

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PolyvinalChlorideCommonName

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineSimplifiedMolecularInputLineEntry

AmlodipineExample

https://chem.nlm.nih.gov/chemidplus/rn/88150-42-9

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMolecularFormula

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/EVMPD-SUB05467MIG

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineAsReferenceStrengthInNorvascPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateMolecularWeight

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PolyvinylChloride

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMolecularWeight

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineEMCMedicinalProduct

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMolecularStructure

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlisterPackagingMethod

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateMolecularFormula

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBoxConstituency

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMolecularFormulaByMoiety

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/UNII-FAS0DJC51V

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlisterAsStartingMaterial

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrate

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateDenominatorInNorvascPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/UNII-1J444QC288

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylatePresentationStrengthInNorvasc

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateOfficialName

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateComposition

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineNumeratorInNorvascPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineEMCComposition

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineCommonName

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateAsActiveIngredientInAmlodipineEMCPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PaperboardCommonName

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateComposition

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineNumeratorInAmlodipineEMCPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateNumeratorInAmlodipineEMCPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateMolecularFormula

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineDenominatorInAmlodipineEMCPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylate

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/UNII-864V2Q084H

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateOfficialName

AmlodipineExample

https://www.ebi.ac.uk/chebi/chebiOntology.do?chebiId=CHEBI:2668

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateMolecularFormulaByMoiety

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateDenominatorInAmlodipineEMCPresentationStrength

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateMolecularWeight

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateSimplifiedMolecularInputLineEntry

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascAsStartingMaterial

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ExtensionTBD/hasLegalStatusOfSupply

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ExtensionTBD/hasAdministrableDoseForm

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ExtensionTBD/hasAuthorizedPharmaceuticalForm

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ExtensionTBD/hasFullIndicationText

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-2-MI-I-100000078041

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-5-I-100000088586

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/IE-100000833-00000003-ManufacturedItem5

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances//substances/100000078041

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-1-I-100000087105

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-1-I-100000076135

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-1-I-100000078041

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances//substances/100000080121

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-1-I-100000093305

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-1-I-100000092217

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/IE-100000833-00000003-0003-SKU

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances//substances/100000076429

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances//substances/100000090493

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/IE-100000833-00000003-BlisterConsituent2

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-2-MI-ProductComposition

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-1-I-100000078762

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances//substances/100000076135

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-5-I-100000093305

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/IE-100000833-00000003-BlisterConsituent5

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-1-I-100000076427

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/IE-100000833-00000003-ManufacturedItem1

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-5-I-100000087105

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/IE-100000833-00000003-BlisterConsituent4

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-2

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/IE-100000833-00000003-ManufacturedItem3

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-5-I-100000078762

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances//substances/100000078762

QlairaExample

https://spor.ema.europa.eu/smswi/#/products//products/00006006-2-MI-I-100000080121