Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA 2.0.0-ballot - STU2
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@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:ValueSet ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "pqcmc-batch-utilization-terminology"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet pqcmc-batch-utilization-terminology</b></p><a name=\"pqcmc-batch-utilization-terminology\"> </a><a name=\"hcpqcmc-batch-utilization-terminology\"> </a><a name=\"pqcmc-batch-utilization-terminology-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C133994</td><td>Bioequivalence</td></tr><tr><td>C133992</td><td>Clinical</td></tr><tr><td>C133990</td><td>Commercial</td></tr><tr><td>C133991</td><td>Development</td></tr><tr><td>C133993</td><td>Validation</td></tr><tr><td>C185328</td><td>Stability Study</td></tr></table></li></ul></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ fhir:v "brr" ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.36.48.35" ] ] ) ; # fhir:version [ fhir:v "2.0.0-ballot"] ; # fhir:name [ fhir:v "PqcmcBatchUtilizationTerminology"] ; # fhir:title [ fhir:v "Batch utilization Terminology"] ; # fhir:status [ fhir:v "active"] ; # fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # fhir:date [ fhir:v "2024-12-12T19:00:52+00:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "brr@lists.HL7.org" ] ] ) ] ) ; # fhir:description [ fhir:v "Terminology used to qualify the information pertaining to batch utilization in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."] ; # fhir:jurisdiction ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "US" ] ; fhir:display [ fhir:v "United States of America" ] ] ) ] ) ; # fhir:compose [ ( fhir:include [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; ( fhir:concept [ fhir:code [ fhir:v "C133994" ] ; fhir:display [ fhir:v "Bioequivalence" ] ] [ fhir:code [ fhir:v "C133992" ] ; fhir:display [ fhir:v "Clinical" ] ] [ fhir:code [ fhir:v "C133990" ] ; fhir:display [ fhir:v "Commercial" ] ] [ fhir:code [ fhir:v "C133991" ] ; fhir:display [ fhir:v "Development" ] ] [ fhir:code [ fhir:v "C133993" ] ; fhir:display [ fhir:v "Validation" ] ] [ fhir:code [ fhir:v "C185328" ] ; fhir:display [ fhir:v "Stability Study" ] ] ) ] ) ] . #