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: Strength Type

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: StrengthExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.33

Strength Type (for API)

Context of Use

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

- Element ID: `Ingredient.substance.strength`

Usage info

Usages:

- Use this Extension: Drug Product Component
- Examples for this Extension: Bundle/DescriptionCompositionBundle

### 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 | Strength Type
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"
value[x] | S | 1..1 | CodeableConcept | Strength Type (for API) Binding: Strength Type Terminology (required)
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Strength Type
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/strength-extension"
value[x] | S | 1..1 | CodeableConcept | Strength Type (for API) Binding: Strength Type Terminology (required)
Documentation for this format

This structure is derived from Extension

Summary

Simple Extension with the type CodeableConcept: Strength Type (for API)

Maturity: 2

Differential View

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Strength Type
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension"
value[x] | S | 1..1 | CodeableConcept | Strength Type (for API) Binding: Strength Type Terminology (required)
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Strength Type
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/strength-extension"
value[x] | S | 1..1 | CodeableConcept | Strength Type (for API) Binding: Strength Type Terminology (required)
Documentation for this format

This structure is derived from Extension

Summary

Simple Extension with the type CodeableConcept: Strength Type (for API)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Extension.value[x] | required | PqcmcStrengthTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology` From this IG

#### 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() |