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GitHub-AmlodipineExample - Added details for manufacturing operation and site for Pfizer #645

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41 changes: 40 additions & 1 deletion EXT/Examples/AmlodipineExample.rdf
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Expand Up @@ -9,6 +9,7 @@
<!ENTITY cmns-dt "https://www.omg.org/spec/Commons/DatesAndTimes/">
<!ENTITY cmns-ge-euj "https://www.omg.org/spec/Commons/EuropeanJurisdiction/EUGovernmentEntitiesAndJurisdictions/">
<!ENTITY cmns-id "https://www.omg.org/spec/Commons/Identifiers/">
<!ENTITY cmns-loc "https://www.omg.org/spec/Commons/Locations/">
<!ENTITY cmns-org "https://www.omg.org/spec/Commons/Organizations/">
<!ENTITY cmns-prd "https://www.omg.org/spec/Commons/ProductsAndServices/">
<!ENTITY cmns-pts "https://www.omg.org/spec/Commons/PartiesAndSituations/">
Expand Down Expand Up @@ -52,6 +53,7 @@
xmlns:cmns-dt="https://www.omg.org/spec/Commons/DatesAndTimes/"
xmlns:cmns-ge-euj="https://www.omg.org/spec/Commons/EuropeanJurisdiction/EUGovernmentEntitiesAndJurisdictions/"
xmlns:cmns-id="https://www.omg.org/spec/Commons/Identifiers/"
xmlns:cmns-loc="https://www.omg.org/spec/Commons/Locations/"
xmlns:cmns-org="https://www.omg.org/spec/Commons/Organizations/"
xmlns:cmns-prd="https://www.omg.org/spec/Commons/ProductsAndServices/"
xmlns:cmns-pts="https://www.omg.org/spec/Commons/PartiesAndSituations/"
Expand Down Expand Up @@ -112,6 +114,7 @@
<owl:imports rdf:resource="https://www.omg.org/spec/Commons/Documents/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/Commons/EuropeanJurisdiction/EUGovernmentEntitiesAndJurisdictions/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/Commons/Identifiers/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/Commons/Locations/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/Commons/Organizations/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/Commons/PartiesAndSituations/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/Commons/ProductsAndServices/"/>
Expand All @@ -123,7 +126,7 @@
<owl:imports rdf:resource="https://www.omg.org/spec/LCC/Countries/ISO3166-1-CountryCodes/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/LCC/Languages/ISO639-1-LanguageCodes/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/MVF/MultipleVocabularyFacility/"/>
<owl:versionIRI rdf:resource="https://spec.pistoiaalliance.org/idmp/ontology/EXT/20241001/Examples/AmlodipineExample/"/>
<owl:versionIRI rdf:resource="https://spec.pistoiaalliance.org/idmp/ontology/EXT/20241201/Examples/AmlodipineExample/"/>
<idmp-chg:hasMaturityLevel rdf:resource="&idmp-chg;Informative"/>
<cmns-av:copyright>Copyright (c) 2022-2024 EDM Council, Inc.</cmns-av:copyright>
<cmns-av:copyright>Copyright (c) 2022-2024 Pistoia Alliance, Inc.</cmns-av:copyright>
Expand Down Expand Up @@ -1071,6 +1074,8 @@
<skos:definition>manufactured item that is a besylate salt of amlodipine, a long-acting long-acting calcium channel blocker (CCB), used to treat high blood pressure (hypertension) and a type of chest pain called angina</skos:definition>
<idmp-uom:hasUnitOfPresentation rdf:resource="https://spor.ema.europa.eu/v1/lists/200000000014/terms/200000002152"/>
<idmp-mprd:hasDoseForm rdf:resource="&idmp-amp;Norvasc-DoseForm"/>
<idmp-mprd:isProducedAtManufacturingSite rdf:resource="&idmp-amp;PGSKalamazooManufacturingSite"/>
<idmp-mprd:isProducedByManufacturingOperation rdf:resource="&idmp-amp;PGSKalamazooOperation"/>
<cmns-col:comprises rdf:resource="https://spor.ema.europa.eu/v2/SubstanceDefinition/100000090079"/>
<cmns-dsg:isDefinedIn rdf:resource="&idmp-amp;NorvascComposition"/>
<cmns-prd:isProducedBy rdf:resource="&idmp-amp;PfizerLaboratoriesAsManufacturer"/>
Expand Down Expand Up @@ -1256,6 +1261,8 @@
<skos:definition>pharmaceutical and medicinal product that is a besylate salt of amlodipine, a long-acting long-acting calcium channel blocker (CCB), used to treat high blood pressure (hypertension) and a type of chest pain called angina</skos:definition>
<skos:note>Norvasc (amlodipine besylate) Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</skos:note>
<idmp-mprd:hasShelfLife rdf:resource="&idmp-amp;Norvasc-ShelfLife"/>
<idmp-mprd:isProducedAtManufacturingSite rdf:resource="&idmp-amp;PGSKalamazooManufacturingSite"/>
<idmp-mprd:isProducedByManufacturingOperation rdf:resource="&idmp-amp;PGSKalamazooOperation"/>
<cmns-col:comprises rdf:resource="&idmp-amp;Norvasc-ManufacturedItem-5mgTablet"/>
<cmns-col:comprises rdf:resource="&idmp-amp;Norvasc-PharmaceuticalProduct"/>
<cmns-prd:isProducedBy rdf:resource="&idmp-amp;PfizerLaboratoriesAsManufacturer"/>
Expand Down Expand Up @@ -1285,7 +1292,10 @@
<owl:NamedIndividual rdf:about="&idmp-amp;NorvascPackagedMedicinalProduct">
<rdf:type rdf:resource="&idmp-mprd;PackagedMedicinalProduct"/>
<rdfs:label>Norvasc packaged medicinal product</rdfs:label>
<idmp-mprd:isProducedAtManufacturingSite rdf:resource="&idmp-amp;PGSKalamazooManufacturingSite"/>
<idmp-mprd:isProducedByManufacturingOperation rdf:resource="&idmp-amp;PGSKalamazooOperation"/>
<cmns-col:comprises rdf:resource="&idmp-amp;NorvascBox"/>
<cmns-prd:isProducedBy rdf:resource="&idmp-amp;PfizerLaboratoriesAsManufacturer"/>
</owl:NamedIndividual>

<owl:NamedIndividual rdf:about="&idmp-amp;NorvascTherapeuticIndicationTextInDenmark">
Expand All @@ -1310,6 +1320,30 @@
<cmns-txt:hasTextValue>P015011211</cmns-txt:hasTextValue>
</owl:NamedIndividual>

<owl:NamedIndividual rdf:about="&idmp-amp;PGSKalamazooLocation">
<rdf:type rdf:resource="&cmns-loc;PhysicalLocation"/>
<rdfs:label>PGS Kalamazoo physical location</rdfs:label>
<cmns-dsg:hasDescription>Kalamazoo, Michigan, USA</cmns-dsg:hasDescription>
<cmns-prd:situates rdf:resource="&idmp-amp;PGSKalamazooManufacturingSite"/>
<cmns-rlcmp:playsRole rdf:resource="&idmp-amp;PGSKalamazooManufacturingSite"/>
</owl:NamedIndividual>

<owl:NamedIndividual rdf:about="&idmp-amp;PGSKalamazooManufacturingSite">
<rdf:type rdf:resource="&idmp-mprd;ManufacturingSite"/>
<rdfs:label>PGS Kalamazoo manufacturing site</rdfs:label>
<cmns-dsg:hasDescription>The largest manufacturing site in the Pfizer network is located in Kalamazoo, Michigan. This 1,300 acre facility manufactures active pharmaceutical ingredients (API), drug products (DP) and medical devices.</cmns-dsg:hasDescription>
<cmns-loc:hasLocation rdf:resource="&idmp-amp;PGSKalamazooLocation"/>
<cmns-rlcmp:isPlayedBy rdf:resource="&idmp-amp;PGSKalamazooLocation"/>
</owl:NamedIndividual>

<owl:NamedIndividual rdf:about="&idmp-amp;PGSKalamazooOperation">
<rdf:type rdf:resource="&idmp-mprd;ManufacturingOrBusinessOperation"/>
<rdfs:label>PGS Kalamazoo operation</rdfs:label>
<cmns-cls:isClassifiedBy rdf:resource="https://spor.ema.europa.eu/v1/lists/100000160406/terms/100000160467"/>
<cmns-org:isManagedBy rdf:resource="&idmp-amp;PfizerLaboratoriesAsManufacturer"/>
<cmns-prd:isSituatedAt rdf:resource="&idmp-amp;PGSKalamazooManufacturingSite"/>
</owl:NamedIndividual>

<owl:NamedIndividual rdf:about="&idmp-amp;PfizerApS">
<rdf:type rdf:resource="&cmns-org;LegalEntity"/>
<rdfs:label>Pfizer ApS</rdfs:label>
Expand Down Expand Up @@ -1337,11 +1371,13 @@
<rdf:type rdf:resource="&cmns-org;LegalEntity"/>
<rdfs:label>Pfizer Inc.</rdfs:label>
<cmns-dsg:hasDescription>American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City.</cmns-dsg:hasDescription>
<cmns-loc:hasLocation rdf:resource="&idmp-amp;PGSKalamazooLocation"/>
</owl:NamedIndividual>

<owl:NamedIndividual rdf:about="&idmp-amp;PfizerLaboratoriesAsManufacturer">
<rdf:type rdf:resource="&idmp-sub;Manufacturer"/>
<rdfs:label>Pfizer Laboratories as manufacturer</rdfs:label>
<cmns-org:manages rdf:resource="&idmp-amp;PGSKalamazooOperation"/>
<cmns-prd:produces rdf:resource="&idmp-amp;Norvasc-ManufacturedItem-5mgTablet"/>
<cmns-rlcmp:isPlayedBy rdf:resource="&idmp-amp;PfizerInc"/>
</owl:NamedIndividual>
Expand Down Expand Up @@ -2910,7 +2946,10 @@
<idmp-sub:hasSubstanceName rdf:resource="https://gsrs.ncats.nih.gov/api/v1/substances/864V2Q084H-CommonName-English-AMLODIPINE_BESILATE"/>
<idmp-sub:hasSubstanceName rdf:resource="https://gsrs.ncats.nih.gov/api/v1/substances/864V2Q084H-OfficialName-English-AMLODIPINE_BESYLATE"/>
<idmp-sub:hasSubstanceName rdf:resource="https://gsrs.ncats.nih.gov/api/v1/substances/864V2Q084H-Systematic-English-3-ETHYL_5-METHYL_2-(2-AMINOETHOXYMETHYL)-4-(2-CHLOROPHENYL)-1,4-DIHYDRO-6-METHYLPYRIDINE-3,5-DICARBOXYLATE_MONOBENZENESULPHONATE"/>
<idmp-mprd:isProducedAtManufacturingSite rdf:resource="&idmp-amp;PGSKalamazooManufacturingSite"/>
<idmp-mprd:isProducedByManufacturingOperation rdf:resource="&idmp-amp;PGSKalamazooOperation"/>
<cmns-id:isIdentifiedBy rdf:resource="&idmp-nara;GlobalSubstanceRegistrationSystem-UniqueIngredientNumber-864V2Q084H"/>
<cmns-prd:isProducedBy rdf:resource="&idmp-amp;PfizerLaboratoriesAsManufacturer"/>
</owl:NamedIndividual>

<owl:NamedIndividual rdf:about="https://spor.ema.europa.eu/v2/SubstanceDefinition/100000090079-Composition">
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23 changes: 23 additions & 0 deletions etc/CQ/Example/uc_cmc_cq1.sparql
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@@ -0,0 +1,23 @@
# UC-CMC-CQ 1: Which manufacturing site <site> is producing which packaged medicinal product <pmp>?
PREFIX cmns-dsg: <https://www.omg.org/spec/Commons/Designators/>
PREFIX cmns-prd: <https://www.omg.org/spec/Commons/ProductsAndServices/>
PREFIX cmns-rlcmp: <https://www.omg.org/spec/Commons/RolesAndCompositions/>
PREFIX cmns-txt: <https://www.omg.org/spec/Commons/TextDatatype/>
PREFIX idmp-mprd: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/>
PREFIX idmp-spor: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/>
PREFIX idmp-sub: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/>
PREFIX idmp-amp: <https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/>
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#>
PREFIX rdfs: <http://www.w3.org/2000/01/rdf-schema#>
PREFIX owl: <http://www.w3.org/2002/07/owl#>


SELECT DISTINCT ?site

WHERE {
# Bind Variable packaged medicinal product <$PackagedMedicinalProduct>
# Example for Norvasc: <https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackagedMedicinalProduct>
BIND(uc_cmc_cq1_parameter_1 AS $PackagedMedicinalProduct )
$PackagedMedicinalProduct idmp-mprd:isProducedAtManufacturingSite ?site
?site a idmp-mprd:ManufacturingSite .
}
19 changes: 19 additions & 0 deletions etc/CQ/Example/uc_cmc_cq2.sparql
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@@ -0,0 +1,19 @@
# UC-CMC-CQ 2: Which manufacturing site <site> is producing which medicinal product <m>? – FDA would ask for this in the application
PREFIX cmns-dsg: <https://www.omg.org/spec/Commons/Designators/>
PREFIX cmns-rlcmp: <https://www.omg.org/spec/Commons/RolesAndCompositions/>
PREFIX cmns-txt: <https://www.omg.org/spec/Commons/TextDatatype/>
PREFIX idmp-mprd: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/>
PREFIX idmp-spor: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/>
PREFIX idmp-sub: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/>
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#>
PREFIX rdfs: <http://www.w3.org/2000/01/rdf-schema#>
PREFIX owl: <http://www.w3.org/2002/07/owl#>


SELECT DISTINCT ?medicinalProduct ?site

WHERE {
?medicinalProduct a idmp-mprd:MedicinalProduct .
?medicinalProduct idmp-mprd:isProducedAtManufacturingSite ?site .
?site a idmp-mprd:ManufacturingSite .
}
12 changes: 12 additions & 0 deletions etc/CQ/Example/uc_cmc_cq3.sparql
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@@ -0,0 +1,12 @@
# UC-CMC-CQ 3: Which manufacturing site <site> is producing which substance <sub>?
PREFIX cmns-dsg: <https://www.omg.org/spec/Commons/Designators/>
PREFIX cmns-rlcmp: <https://www.omg.org/spec/Commons/RolesAndCompositions/>
PREFIX cmns-txt: <https://www.omg.org/spec/Commons/TextDatatype/>
PREFIX idmp-mprd: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/>
PREFIX idmp-spor: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/>
PREFIX idmp-sub: <https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/>
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#>
PREFIX rdfs: <http://www.w3.org/2000/01/rdf-schema#>
PREFIX owl: <http://www.w3.org/2002/07/owl#>

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Something seems to be missing here.


16 changes: 15 additions & 1 deletion etc/unit_tests/configs/idmp_tests_config.yaml
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Expand Up @@ -193,4 +193,18 @@ uc3_cq3_tests:
uc3_cq3_parameter_1: "100000073619"
expected_output: "cq_expected_results/IDMP/uc3_cq3_expected_results.json"


uc_cmc_cq1_tests:
sparql_template: "cq_templates/uc_cmc_cq1.sparql"
parameters:
uc_cmc_cq1_parameter_1: "<https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackagedMedicinalProduct>"
expected_output: "cq_expected_results/IDMP/uc_cmc_cq1_expected_results.json"

uc_cmc_cq2_tests:
sparql_template: "cq_templates/uc_cmc_cq2.sparql"
expected_output: "cq_expected_results/IDMP/uc_cmc_cq2_expected_results.json"

uc_cmc_cq3_tests:
sparql_template: "cq_templates/uc_cmc_cq3.sparql"
parameters:
uc_cmc_cq3_parameter_1: "<https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackagedMedicinalProduct>"
expected_output: "cq_expected_results/IDMP/uc_cmc_cq3_expected_results.json"
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@@ -0,0 +1,17 @@
{
"head": {
"vars": [
"site"
]
},
"results": {
"bindings": [
{
"site": {
"type": "uri",
"value": "https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PGSKalamazooManufacturingSite"
}
}
]
}
}
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@@ -0,0 +1,22 @@
{
"head": {
"vars": [
"medicinalProduct",
"site"
]
},
"results": {
"bindings": [
{
"medicinalProduct": {
"type": "uri",
"value": "https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMedicinalProduct"
},
"site": {
"type": "uri",
"value": "https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PGSKalamazooManufacturingSite"
}
}
]
}
}
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