Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 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
Standards status: Trial-use Maturity Level: 2 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

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

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

 

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()