Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

## : DiagnosticReport - Drug Analysis - example, stability - TTL Representation

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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:DiagnosticReport ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "diagnosticreport-analysis-drug-pq-stability-prod"] ; #  stability results report ,  <id value="6f4a3311-92c5-2b4a-533e-76341e414c63"/> from bundle-drug-product-stability-pq-ex1
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><h2><span title=\"Codes: {http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type Stability Study Report - 18 months}\">Stability Study Report - 18 months</span> </h2><table class=\"grid\"><tr><td>When For</td><td>2020-12</td></tr><tr><td>Identifier:</td><td> <code>https://eudract.europa.eu/example/identifier</code>/ABC1234</td></tr></table><p><b>Report Details</b></p><table class=\"grid\"><tr><td><b>Code</b></td><td><b>Value</b></td><td><b>When For</b></td></tr><tr><td><a href=\"Observation-observation-test-result-longterm25c-initial-1.html\"><span title=\"Codes: \">Test Components - Long-term 25C etc - Initial (XYZ)</span></a></td><td/><td>2023-01-01 12:00:00+0000</td></tr></table><div><p>The samples have been assessed for initial period; no shelf life determined.</p>\n</div></div>"
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol" ]     ] #  this was new and was a broken link, reverted to last one , reference value=\"PlanDefinition\/c96cb248-1408-79fc-1f47-b17a6b2e4b54\"\/
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
    fhir:text [ fhir:v "information about statistical model utilized to interpret stability study results" ] #  #223 ,  Want to use studyDesign, but problem is that this is CodeableConcept, which allows text. However when you use text, you then\n                            have no place to put a context. Ideally this would be a code\/code pair.\n                            Code says \"statistical model\", code (or text) then says what it is      ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-orientation"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "horizontal" ] ;
    fhir:display [ fhir:v "horizontal" ]       ] ) ;
    fhir:text [ fhir:v "Horizontal" ]     ]
      ] ) ; #
      fhir:identifier ( [
    fhir:system [ fhir:v "https://eudract.europa.eu/example/identifier"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "ABC1234" ]
      ] ) ; #
      fhir:status [ fhir:v "final"] ; #
      fhir:code [
        ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "Stability Study Report - 18 months" ] ;
    fhir:display [ fhir:v "Stability Study Report - 18 months" ]     ] )
      ] ; #
      fhir:effective [
    fhir:v "2020-12"^^xsd:gYearMonth ;
        ( fhir:extension [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
            ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/time-point-description"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "Delayed Start Code" ] ;
    fhir:display [ fhir:v "Delayed Start Code" ]         ] ) ;
    fhir:text [ fhir:v "Refrigerated delayed testing" ]       ] #                <extension url=\"http:\/\/accumulus.org\/fhir\/extension\/timePointDescription\">     ] ) #  start of stability test
      ] ; #
      fhir:performer ( [
    fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ]
      ] ) ; #
      fhir:result ( [
    fhir:reference [ fhir:v "Observation/observation-test-result-longterm25c-initial-1" ]
      ] ) ; #    Abbreviated Results, showing only longterm25c-initial-1 of set of 3. Addotional groups of results would be added over time (18 mo., etc.).
      fhir:conclusion [ fhir:v "The samples have been assessed for initial period; no shelf life determined."] . #    <result>
    #      <reference value="Observation/observation-test-result-longterm25c-initial-2"/>
    #   </result>
    #   <result>
    #      <reference value="Observation/observation-test-result-longterm25c-initial-3"/>
    #   </result>