Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0 - STU1
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0 - STU1
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio | Version: 1.0.0 | |||
| Active as of 2024-12-11 | Computable Name: AmountRatio | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.60 | ||||
represent an amount as a ratio in ManufacturedItemDefinition
Context of Use
This extension may be used on the following element(s):
Usage info
Usage:
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Extension |
?! | 0..* | Extension | Amount Ratio |
  extension |
0..0 | |||
| url |
1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio" | |
  value[x] |
S | 1..1 | Ratio | Value of extension |
  numerator |
S | 1..1 | Quantity | Amount Numeric Numerator |
  value |
S | 1..1 | decimal | Numerical value (with implicit precision) |
| denominator |
S | 1..1 | SimpleQuantity | Amount Numeric Denominator Binding: Non-Percentage Units (required) |
| value |
S | 1..1 | decimal | Numerical value (with implicit precision) |
| unit |
S | 1..1 | string | Unit representation |
| code |
S | 1..1 | code | Coded form of the unit |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension |
?! | 0..* | Extension | Amount Ratio |
 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/pq-amount-ratio" | |
| value[x] |
S | 1..1 | Ratio | 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 | |
| numerator |
SΣC | 1..1 | Quantity | Amount Numeric Numerator |
| 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 |
Σ | 0..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 |
| denominator |
SΣC | 1..1 | SimpleQuantity | Amount Numeric Denominator Binding: Non-Percentage Units (required) |
| 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) |
| unit |
SΣ | 1..1 | string | Unit representation |
| system |
ΣC | 0..1 | uri | System that defines coded unit form |
| code |
SΣC | 1..1 | code | Coded form of the unit |
| Documentation for this format | ||||
This structure is derived from Extension
Differential View
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension |
?! | 0..* | Extension | Amount Ratio |
| extension |
0..0 | |||
| url |
1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio" | |
| value[x] |
S | 1..1 | Ratio | Value of extension |
| numerator |
S | 1..1 | Quantity | Amount Numeric Numerator |
| value |
S | 1..1 | decimal | Numerical value (with implicit precision) |
| denominator |
S | 1..1 | SimpleQuantity | Amount Numeric Denominator Binding: Non-Percentage Units (required) |
| value |
S | 1..1 | decimal | Numerical value (with implicit precision) |
| unit |
S | 1..1 | string | Unit representation |
| code |
S | 1..1 | code | Coded form of the unit |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension |
?! | 0..* | Extension | Amount Ratio |
| 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/pq-amount-ratio" | |
| value[x] |
S | 1..1 | Ratio | 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 | |
| numerator |
SΣC | 1..1 | Quantity | Amount Numeric Numerator |
| 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 |
Σ | 0..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 |
| denominator |
SΣC | 1..1 | SimpleQuantity | Amount Numeric Denominator Binding: Non-Percentage Units (required) |
| 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) |
| unit |
SΣ | 1..1 | string | Unit representation |
| system |
ΣC | 0..1 | uri | System that defines coded unit form |
| code |
SΣC | 1..1 | code | Coded form of the unit |
| Documentation for this format | ||||
Other representations of profile: CSV, Excel, Schematron
| Path | Conformance | ValueSet | URI |
| Extension.value[x].numerator.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0from the FHIR Standard | |
| Extension.value[x].denominator | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG |
| 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() |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0 based on FHIR 5.0.0. Generated 2024-12-11
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