description: Drug Substance (Active Ingredient) nomenclature and characterisation.
package_name: hl7.fhir.us.pq
derivation: constraint
name: DrugSubstanceCharacterisation
type: SubstanceDefinition
elements:
  identifier: {short: optional user designated identifier, mustSupport: true, index: 0}
  classification:
    short: Substance Type
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification'}
    mustSupport: true
    index: 1
  manufacturer:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 2
  supplier:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 3
  characterization:
    mustSupport: true
    index: 4
    elements:
      technique: {type: CodeableConcept, short: Substance Characterisation Technique, mustSupport: true, index: 5}
      description: {short: Analysis Narrative Text and Table, mustSupport: true, index: 6}
      file:
        short: Impurity Analysis Graphic | Impurity Analytical Instrument Data File
        mustSupport: true
        index: 7
        slicing:
          rules: open
          ordered: false
          discriminator:
          - {path: $this, type: profile}
          min: null
          slices:
            AnalysisGraphic:
              match: {}
              schema: {type: Attachment, short: Analysis Graphic, array: true, index: 8}
              min: 0
            AnalyticalInstrumentData:
              match: {}
              schema: {type: Attachment, short: Analytical Instrument Data File, array: true, index: 9}
              min: 0
  code:
    mustSupport: true
    index: 10
    slicing:
      rules: open
      discriminator:
      - {path: code.coding.system, type: value}
      min: 1
      slices:
        unii:
          match:
            code:
              coding: {system: 'http://fdasis.nlm.nih.gov'}
          schema:
            short: UNII
            index: 11
            elements:
              code:
                mustSupport: true
                index: 12
                elements:
                  coding:
                    mustSupport: true
                    index: 13
                    elements:
                      system:
                        pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'}
                        mustSupport: true
                        index: 14
                    required: [system]
                required: [coding]
            required: [code]
        uniProt:
          match:
            code:
              coding: {system: 'https://www.uniprot.org'}
          schema:
            short: UniProt ID
            index: 15
            elements:
              code:
                mustSupport: true
                index: 16
                elements:
                  coding:
                    mustSupport: true
                    index: 17
                    elements:
                      system:
                        pattern: {type: Uri, value: 'https://www.uniprot.org'}
                        mustSupport: true
                        index: 18
                    required: [system]
                required: [coding]
            required: [code]
  name:
    short: Substance Name
    constraint:
      cmc-name-preferred: {human: 'Name.preferred: at most one = true', source: 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-characterisation', severity: error, expression: select(preferred = true).count() < 2}
    mustSupport: true
    index: 19
    elements:
      type:
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type'}
        index: 20
      preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 21}
    slicing:
      rules: closed
      description: Slice based on value pattern
      discriminator:
      - {path: type, type: value}
      min: 1
      slices:
        sub:
          match:
            type:
              coding:
              - {code: C97054, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: Generic Name}
          schema:
            mustSupport: true
            index: 22
            elements:
              name: {short: Generic Name, mustSupport: true, index: 23}
              type:
                mustSupport: true
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: C97054, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: Generic Name}
                index: 24
              preferred: {mustSupport: true, index: 25}
            required: [type]
        gsrs:
          match:
            type:
              coding:
              - {code: C203355, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: GSRS Preferred Term}
          schema:
            mustSupport: true
            index: 26
            elements:
              name: {short: GSRS Preferred Term, mustSupport: true, index: 27}
              type:
                mustSupport: true
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: C203355, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: GSRS Preferred Term}
                index: 28
              preferred: {mustSupport: true, index: 29}
            required: [type]
        isbt:
          match:
            type:
              coding:
              - {code: C95517, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: ISBT-128 DIN}
          schema:
            mustSupport: true
            index: 30
            elements:
              name: {short: ISBT-128 DIN, mustSupport: true, index: 31}
              type:
                mustSupport: true
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: C95517, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: ISBT-128 DIN}
                index: 32
              preferred: {mustSupport: true, index: 33}
            required: [type]
  relationship:
    short: Reference to Drug Substance Impurity
    mustSupport: true
    index: 34
    elements:
      substanceDefinition:
        mustSupport: true
        choices: [substanceDefinitionReference]
        index: 36
      substanceDefinitionReference:
        type: Reference
        mustSupport: true
        choiceOf: substanceDefinition
        refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-substance-impurity']
        index: 37
    required: [substanceDefinition, substanceDefinitionReference]
package_version: cmc-fda-2.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-characterisation
base: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
version: 2.0.0-ballot
required: [name, code, classification]