Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan United States of America flag

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 2.0.0-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

Extension: Target Range

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range Version: 2.0.0-ballot
Active as of 2024-12-04 Computable Name: TargetRange
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.50

The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator

Context of Use

This extension may be used on the following element(s):

  • Element ID PlanDefinition.goal.target

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Complex Extension: The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator

  • low: Quantity: An Extension
  • high: Quantity: An Extension

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Target Range
... extension 2..* Extension ValueNumeric (range)
... Slices for extension Content/Rules for all slices
.... extension:low S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "low"
..... value[x] S 1..1 Quantity Value of extension
...... value S 1..1 decimal Numerical value (with implicit precision)
...... unit S 1..1 string Unit representation
.... extension:high S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "high"
..... value[x] S 1..1 Quantity Value of extension
...... value S 1..1 decimal Numerical value (with implicit precision)
...... unit S 1..1 string Unit representation
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Target Range
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension ValueNumeric (range)
Slice: Unordered, Open by value:url
.... extension:low S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "low"
..... value[x] S 1..1 Quantity Value of extension
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code ΣC 0..1 code Coded form of the unit
.... extension:high S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "high"
..... value[x] S 1..1 Quantity Value of extension
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code ΣC 0..1 code Coded form of the unit
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator

  • low: Quantity: An Extension
  • high: Quantity: An Extension

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Target Range
... extension 2..* Extension ValueNumeric (range)
... Slices for extension Content/Rules for all slices
.... extension:low S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "low"
..... value[x] S 1..1 Quantity Value of extension
...... value S 1..1 decimal Numerical value (with implicit precision)
...... unit S 1..1 string Unit representation
.... extension:high S 1..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "high"
..... value[x] S 1..1 Quantity Value of extension
...... value S 1..1 decimal Numerical value (with implicit precision)
...... unit S 1..1 string Unit representation
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension ?! 0..* Extension Target Range
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension ValueNumeric (range)
Slice: Unordered, Open by value:url
.... extension:low S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "low"
..... value[x] S 1..1 Quantity Value of extension
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code ΣC 0..1 code Coded form of the unit
.... extension:high S 1..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "high"
..... value[x] S 1..1 Quantity Value of extension
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value SΣ 1..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit SΣ 1..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code ΣC 0..1 code Coded form of the unit
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:low.value[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
Extension.extension:high.value[x].comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()