Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, 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-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: A DrugProductDescription for a multilayer product - 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:MedicinalProductDefinition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "5772a6f2-cde1-4903-bfcf-1639340205cc"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"5772a6f2-cde1-4903-bfcf-1639340205cc\"> </a><a name=\"hc5772a6f2-cde1-4903-bfcf-1639340205cc\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MedicinalProductDefinition &quot;5772a6f2-cde1-4903-bfcf-1639340205cc&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-description.html\">Drug Product Description</a></p></div><p><b>description</b>: A tablet consisting of two layers where one provides immediate release and  of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug.</p><p><b>combinedPharmaceuticalDoseForm</b>: TABLET, MULTILAYER <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C42964)</span></p><p><b>route</b>: ORAL <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">PQ-CMC-FDA Temporary Codes</a>#C38288)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg</p><p><b>type</b>: Non-Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-product-name-types.html\">Product Name Types Code Types</a>#NON)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: ASPIRIN</p><p><b>type</b>: scientific name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 200mg</p><p><b>type</b>: strength name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: ACETAMINOPHEN</p><p><b>type</b>: scientific name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 300mg</p><p><b>type</b>: strength name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html\">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote></blockquote></div>"
  ] ; # 
  fhir:description [ fhir:v "A tablet consisting of two layers where one provides immediate release and  of the two drugs (Figure in 3.2.P.1.3). Both immediate-release layers are composed of granules with a matrix layer for the modified release of the drug."] ; # 
  fhir:combinedPharmaceuticalDoseForm [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C42964" ] ;
fhir:display [ fhir:v "TABLET, MULTILAYER" ]     ] )
  ] ; # 
  fhir:route ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C38288" ] ;
fhir:display [ fhir:v "ORAL" ]     ] )
  ] ) ; # 
  fhir:name ( [
fhir:productName [ fhir:v "ASPIRIN 200mg, ACETAMINOPHEN 300mg" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types"^^xsd:anyURI ] ;
fhir:code [ fhir:v "NON" ] ;
fhir:display [ fhir:v "Non-Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Non-Proprietary" ]     ] ;
    ( fhir:part [
fhir:part [ fhir:v "ASPIRIN" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SCI" ]         ] )       ]     ] [
fhir:part [ fhir:v "200mg" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"^^xsd:anyURI ] ;
fhir:code [ fhir:v "STR" ]         ] )       ]     ] [
fhir:part [ fhir:v "ACETAMINOPHEN" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SCI" ]         ] )       ]     ] [
fhir:part [ fhir:v "300mg" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"^^xsd:anyURI ] ;
fhir:code [ fhir:v "STR" ]         ] )       ]     ] )
  ] ) . #