Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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: Release Profile Terminology - TTL Representation

Active as of 2024-12-12

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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-release-profile"] ; # 
  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-release-profile</b></p><a name=\"pqcmc-release-profile\"> </a><a name=\"hcpqcmc-release-profile\"> </a><a name=\"pqcmc-release-profile-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>C42730</td><td>Delayed-Release Profile</td></tr><tr><td>C42713</td><td>Extended-Release Profile</td></tr><tr><td>C42669</td><td>Immediate Release Profile</td></tr><tr><td>C48660</td><td>Not Applicable</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-release-profile"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.36.48.21" ]
  ] ) ; # 
  fhir:version [ fhir:v "2.0.0-ballot"] ; # 
  fhir:name [ fhir:v "PqcmcReleaseProfile"] ; # 
  fhir:title [ fhir:v "Release Profile 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 "A category of terminology used to qualify the information pertaining to release profile 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 "C42730" ] ;
fhir:display [ fhir:v "Delayed-Release Profile" ]       ] [
fhir:code [ fhir:v "C42713" ] ;
fhir:display [ fhir:v "Extended-Release Profile" ]       ] [
fhir:code [ fhir:v "C42669" ] ;
fhir:display [ fhir:v "Immediate Release Profile" ]       ] [
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ]       ] )     ] )
  ] . #