Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

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Resource Profile: DrugProductComponent - Mappings

Page standards status: Trial-use Maturity Level: 2

Mappings for the pqcmc-component resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameFiveWs Pattern MappingIDMP MappingRIM Mappingdoco
.. Ingredient
administrative.medication
Ingredient
  • Entity
  • Role
  • or Act
... id
... meta
... implicitRules
... text
Act.text?
... contained
N/A
... extension
N/A
... modifierExtension
N/A
... identifier
FiveWs.class
n/a
... status
n/a
... for
n/a
... role
Ingredient.Ingredient Role
... function
n/a
... group
n/a
... allergenicIndicator
Ingredient.Allergenic Indicator
... comment
n/a
... manufacturer
Ingredient.manufacturer
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... role
Ingredient.Manufacturer / Establishment (Organisation)
.... manufacturer
Ingredient.Manufacturer / Establishment (Organisation)
... substance
Ingredient.Substance
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... code
Substance.Substance
.... Slices for strength
Specified Substance.Strength
..... strength:All Slices
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... presentation[x]
Strength.Strength (Presentation)
...... textPresentation
n/a
...... concentration[x]
Strength.Strength (Concentration)
...... textConcentration
n/a
...... basis
n/a
...... measurementPoint
Strength.Measurement Point
...... country
Strength.Country
...... referenceStrength
Strength.Reference Strength
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... substance
Reference Strength.Reference Substance
....... strength[x]
Reference Strength.Reference Strength
....... measurementPoint
Reference Strength.Measurement Point
....... country
Reference Strength.Country
..... strength:amount
Specified Substance.Strength
...... id
n/a
...... Slices for extension
....... extension:strengthFactors
...... modifierExtension
N/A
...... presentation[x]
Strength.Strength (Presentation)
...... textPresentation
n/a
...... Slices for concentration[x]
Strength.Strength (Concentration)
....... concentration[x]:concentrationQuantity
Strength.Strength (Concentration)
........ id
n/a
........ extension
n/a
........ value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
........ comparator
IVL properties
........ unit
PQ.unit
........ system
  • CO.codeSystem
  • PQ.translation.codeSystem
........ code
  • PQ.code
  • MO.currency
  • PQ.translation.code
....... concentration[x]:concentrationRatio
Strength.Strength (Concentration)
........ id
n/a
........ extension
n/a
........ numerator
.numerator
......... id
n/a
......... extension
n/a
......... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
......... comparator
IVL properties
......... unit
PQ.unit
......... system
  • CO.codeSystem
  • PQ.translation.codeSystem
......... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
........ denominator
.denominator
......... id
n/a
......... extension
n/a
......... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
......... comparator
IVL properties
......... unit
PQ.unit
......... system
  • CO.codeSystem
  • PQ.translation.codeSystem
......... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
...... textConcentration
n/a
...... basis
n/a
...... measurementPoint
Strength.Measurement Point
...... country
Strength.Country
...... referenceStrength
Strength.Reference Strength
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... substance
Reference Strength.Reference Substance
....... strength[x]
Reference Strength.Reference Strength
....... measurementPoint
Reference Strength.Measurement Point
....... country
Reference Strength.Country
..... strength:percent
Specified Substance.Strength
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... presentation[x]
Strength.Strength (Presentation)
...... textPresentation
n/a
...... concentration[x]
Strength.Strength (Concentration)
....... id
n/a
....... extension
n/a
....... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
....... comparator
IVL properties
....... unit
PQ.unit
....... system
  • CO.codeSystem
  • PQ.translation.codeSystem
....... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
...... textConcentration
n/a
...... basis
n/a
...... measurementPoint
Strength.Measurement Point
...... country
Strength.Country
...... referenceStrength
Strength.Reference Strength
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... substance
Reference Strength.Reference Substance
....... strength[x]
Reference Strength.Reference Strength
....... measurementPoint
Reference Strength.Measurement Point
....... country
Reference Strength.Country

doco Documentation for this format