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 1.0.0-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: Optional Denominator

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator Version: 1.0.0-ballot
Active as of 2024-04-04 Computable Name: OptionalDenominator
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.13

The constituent optional denominator is used then the unit is other than 1 per product part.

Context of Use

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

  • Element ID ManufacturedItemDefinition.component.amount
  • Element ID ManufacturedItemDefinition.component.constituent.amount

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

Simple Extension of type Quantity: The constituent optional denominator is used then the unit is other than 1 per product part.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator"
... value[x] 1..1 Quantity Value of extension

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
... id 0..1 id Unique id for inter-element referencing
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type Quantity: The constituent optional denominator is used then the unit is other than 1 per product part.

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator"
... value[x] 1..1 Quantity Value of extension

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
... id 0..1 id Unique id for inter-element referencing
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

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()