diff --git a/ISO/ISO11238-Substances.rdf b/ISO/ISO11238-Substances.rdf index d72a8497..8988c599 100644 --- a/ISO/ISO11238-Substances.rdf +++ b/ISO/ISO11238-Substances.rdf @@ -99,7 +99,7 @@ - + The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221101/ISO11238-Substances.rdf version of this ontology was modified to relax the restriction on the property isStoichiometric with respect to chemical substances to optional from required (IDMP-380), and then reversed per the SME team and to conform with the IDMP standard. The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221201/ISO11238-Substances.rdf version of this ontology was modified to relax the restriction on the property hasStructure with respect to substances, single substances, and moieties to optional from at most one value, to allow for cases where there may be multiples, especially if mapping content from multiple repositories (IDMP-GitHub-244) to add definitions for certain stereochemistry nominals where they were missing (IDMP-GitHub-243), and to refactor concepts including substance, moiety, and add physical substance in order to distinguish specifications for substances, which is the primary perspective of the IDMP standards from physical substances, and rename substance constituency to substance composition, which is better understood by the user community. (IDMP-405) The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230201/ISO11238-Substances.rdf version of this ontology was modified to integrate a revised manufactured item and packaging strategy for UC-2. (IDMP-465) @@ -111,7 +111,7 @@ The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230901/ISO11238-Substances.rdf version of this ontology was augmented to build out the definition of protein substance to complete the requirements specified in clause 7.4 of the ISO 11238 standard and related information in ISO/TS 19844 (IDMP-594), to build out the definition of polymer substance to complete the requirements specified in clause 7.6 of the ISO 11238 standard and related information in ISO/TS 19844 (IDMP-673), and to add details for Organism (IDMP-640). The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20231001/ISO11238-Substances.rdf version of this ontology was augmented to build out the definition of mixture to complete the requirements specified in clause 7.8 of the ISO 11238 standard and related information in ISO/TS 19844 (IDMP-675), to assist in addressing gaps with respect to the top-level class definitions and relationships in the complete model figures for authorized and investigational medicinal product in Annex A and Annex B, respectively, in ISO 11615 (IDMP-677), and to update the conformance points to be current (IDMP-322). The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20231201/ISO11238-Substances.rdf version of this ontology was augmented to build out the definition of source material (Figure 17 in the ISO standard) to support representation of biologics (IDMP-713) and to normalize the use of hasTextualName from MVF rather than from LCC. - The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240301/ISO11238-Substances.rdf version of this ontology was augmented to add SKOS prefLabels for elements that have multiple labels (IDMP-734), to correct a wrong prefix for ReferenceSource, to make starting and resultant material roles disjoint, and clean up URIs that had an erroneous final slash. + The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240301/ISO11238-Substances.rdf version of this ontology was augmented to add SKOS prefLabels for elements that have multiple labels (IDMP-734), to correct a wrong prefix for ReferenceSource, to make starting and resultant material roles disjoint, and clean up URIs that had an erroneous final slash or were ill-formed. Copyright (c) 2022-2024 EDM Council, Inc. Copyright (c) 2022-2024 Pistoia Alliance, Inc. @@ -1346,7 +1346,7 @@ controlled vocabulary for representing the arrangement of atoms for describing chemical structures ISO 11238 Structural Representation vocabulary - https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/idmp-sub;ISO11238-StructuralRepresentationVocabulary + https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ISO11238-StructuralRepresentationVocabulary diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf index 61060bc3..99a8d447 100644 --- a/ISO/ISO11615-MedicinalProducts.rdf +++ b/ISO/ISO11615-MedicinalProducts.rdf @@ -111,7 +111,7 @@ - + The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221001/ISO11615-MedicinalProducts.rdf version of this ontology was modified to rename 'ingredient role's to ingredients for clarification and refine the restrictions relating ingredients to pharmaceutical products and manufactured items per discussion at the Pistoia Alliance Conference Workshop on 3 November 2022 (IDMP-298). It was also extended to include concepts such as process, manufacturing process, process identifier, batch, batch identifier, lot, lot number, and others required in support of the regulatory to manufacturing bridge use case. The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221201/ISO11615-MedicinalProducts.rdf version of this ontology was modified to refactor concepts including substance, moiety, and add physical substance in order to distinguish specifications for substances, which is the primary perspective of the IDMP standards from physical substances, and rename product constituency to product composition, which is better understood by the user community, and to move a couple of restrictions from ingredient to substance, including strength and whether or not that substance is potentially allergenic. (IDMP-405) The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230201/ISO11615-MedicinalProducts.rdf version of this ontology was modified to integrate additional manufacturing and packaging details required for UC-2 (IDMP-465), to make manufactured item and pharmaceutical product disjoint, but both product specifications (IDMP-466), to change the status of this ontology to 'release' (IDMP-525), to add content related to dose forms (IDMP-531, IDMP-538), and to complete the set of ingredient roles specified in the implementation guide for ISO 11615 (IDMP-304). @@ -122,7 +122,7 @@ The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230901/ISO11615-MedicinalProducts.rdf version of this ontology was modified to add package components, devices, and physical characteristics (IDMP-659), to eliminate default codes on Ingredient and InactiveIngredient (IDMP-634), and add characteristics for target populations (IDMP-640). The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20231001/ISO11615-MedicinalProducts.rdf version of this ontology was modified to correct definitions to be compliant with IDMP-O policies (GitHub-501), fill in gaps with respect to the top-level class definitions and relationships in the complete model figures for authorized and investigational medicinal product in Annex A and Annex B, respectively, in ISO 11615 (IDMP-677), and to update the conformance points to be current (IDMP-322). The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20231201/ISO11615-MedicinalProducts.rdf version of this ontology was modified to add content from ISO 11615 that was incomplete but required for representation of jurisdiction-agnostic medicinal products (IDMP-726). - The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240301/ISO11615-MedicinalProducts.rdf version of this ontology was augmented to add SKOS prefLabels for elements that have multiple labels (IDMP-734), and modified to clean up URIs that had an erroneous final slash. + The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240301/ISO11615-MedicinalProducts.rdf version of this ontology was augmented to add SKOS prefLabels for elements that have multiple labels (IDMP-734), and modified to clean up URIs that had an erroneous final slash or do not resolve reliably. Copyright (c) 2022-2024 EDM Council, Inc. Copyright (c) 2022-2024 Pistoia Alliance, Inc. @@ -1021,7 +1021,6 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.21.9 - http://purl.obolibrary.org/obo/PATO_0000014 color colour @@ -1417,7 +1416,6 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.21.4 - http://purl.obolibrary.org/obo/PATO_000001595 depth @@ -1431,7 +1429,6 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli diameter characteristic - http://purl.obolibrary.org/obo/PATO_000001334 length physical characteristic which is equal to the length of any straight line segment that passes through the center of a circle and whose endpoints are on the circular boundary. @@ -1542,7 +1539,6 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.21.2 - http://purl.obolibrary.org/obo/PATO_000000119 height @@ -4431,7 +4427,6 @@ g) therapeutic indication(s) as authorized for the medicinal product. ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.21.8 - http://purl.obolibrary.org/obo/PATO_0000052 @@ -4943,7 +4938,6 @@ g) therapeutic indication(s) as authorized for the medicinal product. ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.21.6 - http://purl.obolibrary.org/obo/PATO_000000918 volume @@ -4961,7 +4955,6 @@ g) therapeutic indication(s) as authorized for the medicinal product. ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.21.5 - http://purl.obolibrary.org/obo/PATO_000000128 weight @@ -4979,7 +4972,6 @@ g) therapeutic indication(s) as authorized for the medicinal product. ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.21.3 - http://purl.obolibrary.org/obo/PATO_000001595 width