StructureDefinition-pqcmc-component

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-component
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-component
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameDrugProductComponent
titleDrug Product Component
date2023-07-17T03:00:13+00:00
descriptionThe amount details about the drug product components to define the product composition in a product unit. Use composition.
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeIngredient
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/Ingredient
Usages
Name Flags Card. Type Description & Constraints doco
. . Ingredient Ingredient
. . . meta
. . . . profile S ..1
. . . Slices for extension Slice: Unordered, Open by value:url
. . . additional-info S 0..1 markdown Drug Product Component Additional Information
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension
. . . for Reference to MedicinalProductDefinition
. . . role Binding: Drug Product Component Function Category Terminology ( required )
. . . substance C cmc-strength-type-cases1: IF Strength Type = Mass THEN Strength Numeric and Strength UOM are Mandatory
cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity.
. . . . code S CodeableReference (Component Substance) Ingredient Substance
. . . . strength S 1..1
. . . . . Slices for extension 1.. Slice: Unordered, Open by value:url
. . . . . strengthFactors S 1..1 (Complex) Strength Extension
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/strength-extension
. . . . . Slices for presentation[x] S 1 .. Slice: Unordered, Open by type:$this
. . . . . . presentationRatio Ratio
. . . . . . presentationQuantity Quantity
. . . . . . presentation[x]:presentationRatio S 0..1 Ratio
. . . . . . . numerator S 1..
. . . . . . . . value S 1.. Product Ingredient Amount Numeric Numerator
. . . . . . . . unit S 1.. Product Ingredient Amount Numeric Numerator UOM
. . . . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . . . . denominator S 1..
. . . . . . . . value S 1.. Product Ingredient Amount Numeric Denominator
. . . . . . . . unit S 1..
. . . . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . . . presentation[x]:presentationQuantity S 0..1 Quantity
. . . . . . . value S 1.. Product Ingredient Amount Numeric
. . . . . . . unit 1..
. . . . . . . code 1.. Binding: Units Of Measure Terminology ( required )
. . . . . textPresentation S 1.. Strength Textual

doco Documentation for this format

Produced 08 Sep 2023