Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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

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

- Element ID: `PlanDefinition.goal.target`

Usage info

Usages:

- Use this Extension: Quality Specification

### Formal Views of Extension Content

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

- Differential Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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"
value[x] |  | 0..0 |  |
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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 | S Σ | 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 | S Σ | 1..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 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 | S Σ | 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 | S Σ | 1..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
url |  | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"
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

Maturity: 2

Differential View

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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"
value[x] |  | 0..0 |  |
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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 | S Σ | 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 | S Σ | 1..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 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 | S Σ | 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 | S Σ | 1..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
url |  | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"
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

Maturity: 2

Other representations of profile: CSV, Excel, Schematron

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Extension.extension:low.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
Extension.extension:high.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |