Package | hl7.fhir.us.pq-cmc-fda |
Type | StructureDefinition |
Id | Id |
FHIR Version | R5 |
Source | http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/StructureDefinition-pqcmc-drug-substance-nomenclature-structure.html |
Url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure |
Version | 2.0.0-ballot |
Status | active |
Date | 2024-12-12T01:58:44+00:00 |
Name | DrugSubstanceNomenclatureStructure |
Title | Substance General Information |
Experimental | False |
Realm | us |
Authority | hl7 |
Description | Substance General Information containing Drug Substance (Active Ingredient) nomenclature (3.2.S.1.1) and Substance Structure (3.2.S.1.2) profile. |
Type | SubstanceDefinition |
Kind | resource |
StructureDefinition | |
cmc-ectd-document-32s10 | CMC eCTD 32S10 Document |
ectd-composition-32s10 | eCTD Substance General Information |
StructureDefinition | |
cmc-organization | Basic Organization |
codeable-concept-text-only | Text Only Codeable Concept |
literal-reference | Literal Reference |
pqcmc-graphic-reference | Graphic Reference |
pqcmc-polymorphic-form | Polymorphic Form |
pqcmc-structure-reference | Structure Data Reference |
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology | Chemical Structure Data File Type Terminology |
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types | Representation Types |
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type | Substance Name Type |
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure | Units Of Measure |
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification | Substance Classification |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition pqcmc-drug-substance-nomenclature-structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
SubstanceDefinition | C | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' cmc-name-isbt: Name.type ISBT 128 required for blood products. cmc-structure-required: A structure is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer','Protein'. cmc-substance-structure-graphic-required: A Substance Structure Graphic is required Required for Small Molecules. Equivalent to classification code equals 'Chemical'. |
identifier | S | 0..1 | Identifier | optional user designated identifier |
classification | S | 1..1 | CodeableConcept | Substance Type Binding: Substance Classification (required) |
manufacturer | S | 1..1 | LiteralReference(Basic Organization) {b} | The entity that creates, makes, produces or fabricates the substance |
supplier | S | 0..1 | LiteralReference(Basic Organization) {b} | An entity that is the source for the substance. It may be different from the manufacturer |
molecularWeight | S | 0..1 | BackboneElement | Molecular Weight |
amount | S | 1..1 | Quantity | Used to capture quantitative values for a variety of elements Binding: Units Of Measure (extensible) |
unit | 0..1 | string | Molecular Weight UOM | |
code | S | 1..1 | code | Coded form of the unit |
structure | SC | 1..1 | BackboneElement | Structural information cmc-structure-representation-required: Either a file or string structure representation is required |
molecularFormula | S | 0..1 | string | Molecular Formula | Biopolymer Sequence |
technique | S | 1..1 | CodeableConceptTextOnly | Substance Characterisation Technique |
Slices for representation | S | 1..* | BackboneElement | Impurity Structure Graphic | Impurity Structure Data File Slice: Unordered, Closed by value:type |
representation:All Slices | Content/Rules for all slices | |||
type | S | 1..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: Representation Types (required) |
representation:graphic | 0..1 | BackboneElement | A graphical, displayable depiction of the structure (e.g. an SVG, PNG) | |
type | 0..1 | CodeableConcept | Graphic Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C54273 | |
document | 1..1 | LiteralReference(Graphic Reference) {b} | Impurity Structure Graphic | |
representation:structureFile | 0..* | BackboneElement | machine-readable representation -- attached file | |
type | 0..1 | CodeableConcept | Structure File Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C103240 | |
document | S | 1..1 | LiteralReference(Structure Data Reference) {b} | Impurity Chemical Structure Data (files, e.g. .SDF, .CIF) |
representation:structureString | 0..* | BackboneElement | machine-readable representation -- plain text | |
type | 0..1 | CodeableConcept | Structure Textual Required Pattern: At least the following | |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C45253 | |
representation | S | 1..1 | string | Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES) |
format | S | 1..1 | CodeableConcept | Drug Substance Impurity Method Type Binding: Chemical Structure Data File Type Terminology (required) |
Slices for code | S | 1..* | BackboneElement | Codes associated with the substance Slice: Unordered, Open by value:code.coding.system |
code:unii | 0..1 | BackboneElement | UNII | |
code | S | 1..1 | CodeableConcept | The specific code |
coding | S | 1..1 | Coding | Code defined by a terminology system |
system | S | 1..1 | uri | Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov |
code:uniProt | 0..1 | BackboneElement | UniProt ID | |
code | S | 1..1 | CodeableConcept | The specific code |
coding | S | 1..1 | Coding | Code defined by a terminology system |
system | S | 1..1 | uri | Identity of the terminology system Required Pattern: https://www.uniprot.org |
Slices for name | SC | 1..* | BackboneElement | Subtance Name Slice: Unordered, Closed by value:type cmc-name-preferred: Name.preferred: at most one = true |
name:All Slices | Content/Rules for all slices | |||
type | 0..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Binding: Substance Name Type (required) | |
preferred | S | 0..1 | boolean | True when the name type is Substance Name |
name:sys | S | 0..1 | BackboneElement | Names applicable to this substance |
name | S | 1..1 | string | Systematic |
type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203357 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Systematic Name | |
preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
name:sub | S | 0..1 | BackboneElement | Names applicable to this substance |
name | S | 1..1 | string | Generic |
type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C97054 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Generic Name | |
preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
name:brand | S | 0..1 | BackboneElement | Names applicable to this substance |
name | S | 1..1 | string | Brand |
type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C71898 | |
display | 1..1 | string | Representation defined by the system Fixed Value: Brand | |
preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
name:gsrs | S | 0..1 | BackboneElement | Names applicable to this substance |
name | S | 1..1 | string | GSRS Preferred Term |
type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203355 | |
display | 1..1 | string | Representation defined by the system Fixed Value: GSRS Preferred Term | |
preferred | S | 0..1 | boolean | If this is the preferred name for this substance |
name:usp | S | 0..1 | BackboneElement | Names applicable to this substance |
name | S | 1..1 | string | USP-NF Established Name |
type | S | 1..1 | CodeableConcept | Name type e.g. 'systematic', 'scientific, 'brand' Required Pattern: At least the following |
coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C203358 | |
display | 1..1 |