Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Resource Profile: DrugProductComponent - Mappings

Active as of 2024-12-12

Mappings for the pqcmc-component resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

DrugProductComponent
Ingredientadministrative.medication
   identifierFiveWs.class

Mappings for IDMP Mapping (https://www.iso.org/obp/ui/#iso:std:iso:11615)

DrugProductComponent
IngredientIngredient
   identifiern/a
   statusn/a
   forn/a
   roleIngredient.Ingredient Role
   functionn/a
   groupn/a
   allergenicIndicatorIngredient.Allergenic Indicator
   commentn/a
   manufacturerIngredient.manufacturer
      roleIngredient.Manufacturer / Establishment (Organisation)
      manufacturerIngredient.Manufacturer / Establishment (Organisation)
   substanceIngredient.Substance
      strengthSpecified Substance.Strength
         presentation[x]Strength.Strength (Presentation)
         textPresentationn/a
         concentration[x]Strength.Strength (Concentration)
         textConcentrationn/a
         basisn/a
         measurementPointStrength.Measurement Point
         countryStrength.Country
         referenceStrengthStrength.Reference Strength
            substanceReference Strength.Reference Substance
            strength[x]Reference Strength.Reference Strength
            measurementPointReference Strength.Measurement Point
            countryReference Strength.Country
      strength (amount)Specified Substance.Strength
         presentation[x]Strength.Strength (Presentation)
         textPresentationn/a
         concentration[x]Strength.Strength (Concentration)
         concentration[x] (concentrationQuantity)Strength.Strength (Concentration)
         concentration[x] (concentrationRatio)Strength.Strength (Concentration)
         textConcentrationn/a
         basisn/a
         measurementPointStrength.Measurement Point
         countryStrength.Country
         referenceStrengthStrength.Reference Strength
            substanceReference Strength.Reference Substance
            strength[x]Reference Strength.Reference Strength
            measurementPointReference Strength.Measurement Point
            countryReference Strength.Country
      strength (percent)Specified Substance.Strength
         presentation[x]Strength.Strength (Presentation)
         textPresentationn/a
         concentration[x]Strength.Strength (Concentration)
         basisn/a
         measurementPointStrength.Measurement Point
         countryStrength.Country
         referenceStrengthStrength.Reference Strength
            substanceReference Strength.Reference Substance
            strength[x]Reference Strength.Reference Strength
            measurementPointReference Strength.Measurement Point
            countryReference Strength.Country

Mappings for RIM Mapping (http://hl7.org/v3)

DrugProductComponent
IngredientEntity, Role, or Act
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   manufacturer
      idn/a
      extensionn/a
      modifierExtensionN/A
   substance
      idn/a
      extensionn/a
      modifierExtensionN/A
      coden/a
      strength
         idn/a
         extensionn/a
         modifierExtensionN/A
         concentration[x]
         referenceStrength
            idn/a
            extensionn/a
            modifierExtensionN/A
      strength (amount)
         idn/a
         modifierExtensionN/A
         concentration[x]
         concentration[x] (concentrationQuantity)
            idn/a
            extensionn/a
            valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
            comparatorIVL properties
            unitPQ.unit
            systemCO.codeSystem, PQ.translation.codeSystem
            codePQ.code, MO.currency, PQ.translation.code
         concentration[x] (concentrationRatio)
            idn/a
            extensionn/a
            numerator.numerator
               idn/a
               extensionn/a
               valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
               comparatorIVL properties
               unitPQ.unit
               systemCO.codeSystem, PQ.translation.codeSystem
               codePQ.code, MO.currency, PQ.translation.code
            denominator.denominator
               idn/a
               extensionn/a
               valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
               unitPQ.unit
               systemCO.codeSystem, PQ.translation.codeSystem
               codePQ.code, MO.currency, PQ.translation.code
         referenceStrength
            idn/a
            extensionn/a
            modifierExtensionN/A
      strength (percent)
         idn/a
         extensionn/a
         modifierExtensionN/A
         concentration[x]
            idn/a
            extensionn/a
            valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
            comparatorIVL properties
            unitPQ.unit
            systemCO.codeSystem, PQ.translation.codeSystem
            codePQ.code, MO.currency, PQ.translation.code
         referenceStrength
            idn/a
            extensionn/a
            modifierExtensionN/A