Release Notes 0.4.0

Release Notes 0.4.0

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Ontology Development

Summary

A number of significant extensions were added in the Q2 0.4.0 release, including (1) the ability to answer new competency questions, (2) integration of additional data sources as well as improved use of existing sources for better question answering / mapping, (3) increased coverage more generally of some areas of the ISO standards, (4) integration of new examples, and (5) refinements to improve usability and address user feedback. Some of the major changes made include the following.

  1. New Competency Question Answering - the primary additions in Q2 involved UC3 - Therapeutic Indications. See UC3 - Use Case Therapeutic Indication for details. Preliminary coverage was added in Q2, and additional competency questions will be supported in Q3. Note that one of the more important changes with respect to question answering is that we now use the competency questions and sample answers as part of regression testing. Three of our example ontologies will be continuously updated in order to fully support this testing and provide examples that can be used by the pharma participants as good examples for mapping purposes: Amlodipine, Terlipressin, and the EU Clinical Trials example, all of which are in GitHub under /EXT/Examples. 

  2. Data Source Integration and Support – in Q2 we've added preliminary support for EDQM and have continued to improve mappings and support for GSRS and SPOR. Note that the IRIs in the SPOR data are not consistent with the guidelines for IRIs for use in RDF/OWL, so we have ongoing challenges there are representing the content on the Pistoia site as a work-around.

  3. Increased Coverage of the ISO Standards – the main changes to the ontologies this quarter include completion of coverage of the forthcoming Annex L to the ISO 11238 implementation guide (ISO 19844) at the substance and chemical substance levels. We've also increased coverage of ISO 11615 with respect to ingredients and related concepts, which led to some of the renaming indicated by deprecated resources (which are mapped to their replacements). We also added some preliminary content for ISO 11239, Pharmaceutical Dose Forms, pending review of the revised standard once it is publicly available.

  4. New Examples – The documentation includes a number of examples that are not covered in the ontology per se, but one new example ontology covers the Qlaira content from the EMA PMS Implementation Guide, Chapter 8. Existing examples have been extended as well, to include new content for testing the latest additions and updates in the ontologies.

  5. Usability – see the detailed GitHub revisions for usability related revisions.

Deprecated Resources

The following 13 resources are considered as deprecated in 0.4.0.

Resources

Comparison with the 0.3.0 version of the IDMP Ontology

By the Numbers

Three new ontologies were added:

  1. StatisticalMeasures

  2. ISO11238-Substances-DeprecatedElements

  3. StructuredCollections

The following ontologies were changed:

Ontology Short Name

New Resources

Deleted Resources

Modified Resources

Ontology Short Name

New Resources

Deleted Resources

Modified Resources

AmlodipineExample

9

4

14

ChangeManagement

0

0

1

Documents

0

0

1

EasternEuropeGovernmentEntitiesAndJurisdictions

0

0

2

EUGovernmentEntitiesAndJurisdictions

0

0

3

EuropeanUnionClinicalTrialsRegister

0

0

1

ISO11238-RegistrationAuthorities

6

0

2

ISO11238-Substances

155

9

53

ISO11239-PharmaceuticalDoseForms

18

0

4

ISO11615-MedicinalProducts

42

0

42

ISO11616-PharmaceuticalProducts

2

0

1

Organisations

0

0

2

PartiesAndSituations

0

0

1

ProductsAndServices

0

0

20

QlairaExample

74

74

1

QuantitiesAndUnits

1

0

1

RegistrationAuthorities

0

0

4

RegulatoryAgencies

0

0

2

SubstancesProductsOrganisationsReferentials

0

0

1

TerlipressinExample

2

2

13

WesternEuropeGovernmentEntitiesAndJurisdictions

0

0

1

Detailed View

resources in 0.3.0 but not 0.4.0 release

ontology

resources in 0.3.0 but not 0.4.0 release

ontology

resources in 0.3.0 but not 0.4.0 release

TerlipressinExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/TerlipressinExample/TerlipressinAcetateSUN

TerlipressinExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/TerlipressinExample/TerlipressinAsReferenceStrengthInTerlipressinAcetate1MgPerAmpouleSolutionForInjection

ISO11238-Substances

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

ISO11238-Substances

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

ISO11238-Substances

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

ISO11238-Substances

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

ISO11238-Substances

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

ISO11238-Substances

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

ISO11238-Substances

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

ISO11238-Substances

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

ISO11238-Substances

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

AmlodipineExample

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

AmlodipineExample

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

AmlodipineExample

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

AmlodipineExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000087105

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000093305

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-1-I-100000090493

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0001-SKU

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances/100000093305

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000078762

QlairaExample

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

QlairaExample

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

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000090493

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-BlisterConsituent1

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000087133

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-1-I-100000076429

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0002-1

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0003-1-Constituency

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-BlisterConsituent3

QlairaExample

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

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances/100000092217

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-1-I-100000088586

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-1-I-100000080121

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-5-I-100000080121

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances/100000087105

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-3

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0002

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-5-I-100000092217

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000076427

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0003-1

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances/100000076427

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-ManufacturedItem2

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-4

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000088586

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000092217

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-2-MI-I-100000076135

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0002-1-Constituency

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances/100000088586

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0001

QlairaExample

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

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/IE-100000833-00000003-0001-1

QlairaExample

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

QlairaExample

https://spor.ema.europa.eu/smswi/#/substances/100000087133

QlairaExample

https://spor.ema.europa.eu/smswi/#/products/00006006-5-I-100000076135

QlairaExample

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

QlairaExample

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

QlairaExample