diff --git a/ISO/ISO11238-Substances.rdf b/ISO/ISO11238-Substances.rdf
index efa89622..60cbc03a 100644
--- a/ISO/ISO11238-Substances.rdf
+++ b/ISO/ISO11238-Substances.rdf
@@ -104,7 +104,7 @@
The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230502/ISO11238-Substances.rdf version of this ontology was modified to integrate content related to modifications from Figure 15 in ISO 11238, corresponding to clause 6.6 and Figure 8 in the implementation guide (IDMP-540), to support isotopes and nuclides as in ISO 11238, Figure 14 (IDMP-539), to move deprecated elements to a separate ontology, and to support additional reference information from Figure 16 in ISO 11238, corresponding to clause 6.6 and Figure 8 in the implementation guide (IDMP-522), addressed punning issues with modification method type, aligned the ontology with the revised basis of strength pattern (IDMP-582), and to add an axiom indicating that certain elements have data that can be used for testing purposes.
The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230601/ISO11238-Substances.rdf version of this ontology was modified to rename hasSimplifiedMolecularInputLineEntrySpecification to hasSMILES and to incorporate the ability to define controlled vocabularies that may or may not be jurisdiction-specific (IDMP-533).
The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230701/ISO11238-Substances.rdf version of this ontology was modified to add structural representations including molfile.
- The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230801/ISO11238-Substances.rdf version of this ontology was modified to reflect the migration of some content in Commons from the Parties and Situations ontology to a new Roles and Compositions ontology at OMG (IDMP-642), to incorporate additional content for structurally diverse substances (IDMP-635), and to (1) rename cmns-doc;isSpecifiedBy to cmns-doc;isSpecifiedIn, and (2) rename concepts including Quantity, QuantityValue, and QuantityValueRange to ScalarQuantity, ScalarQuantityValue, and ScalarQuantityValueRange per the Commons 1.1 release (IDMP-655).
+ The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230801/ISO11238-Substances.rdf version of this ontology was modified to reflect the migration of some content in Commons from the Parties and Situations ontology to a new Roles and Compositions ontology at OMG (IDMP-642), to incorporate additional content for structurally diverse substances (IDMP-635), to (1) rename cmns-doc;isSpecifiedBy to cmns-doc;isSpecifiedIn, and (2) rename concepts including Quantity, QuantityValue, and QuantityValueRange to ScalarQuantity, ScalarQuantityValue, and ScalarQuantityValueRange per the Commons 1.1 release (IDMP-655), and to augment the definition of nucleic acid substance to complete the requirements specified in clause 7.5 of the ISO 11238 standard and related information in ISO/TS 19844 (IDMP-592).
Copyright (c) 2022-2023 EDM Council, Inc.
Copyright (c) 2022-2023 Pistoia Alliance, Inc.
@@ -851,6 +851,21 @@
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ISO11238-OfficialNameStatusVocabulary/
+
+
+
+
+ ISO 11238 - oligo nucleotide type vocabulary
+ controlled vocabulary used to distinguish a single stranded oligo nucleotide from a double stranded gene or rDNA vaccine
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+ controlled vocabulary used to distinguish a single stranded oligo nucleotide from a double stranded gene or rDNA vaccine
+
+ ISO 11238 Oligo Nucleotide Type vocabulary
+ https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ISO11238-OligoNucleotideTypeVocabulary/
+
+
@@ -1164,6 +1179,51 @@
No controlled vocabulary is defined in either ISO 11238 or the ISO/TS 19844 implementation guide.
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+
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+ 1
+
+
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+
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+ 1
+
+
+
+
+
+
+
+ 1
+
+
+ linkage
+ connection between sugar residues
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+
+
@@ -2066,14 +2126,197 @@
+
+
+
+
+ 1
+
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+
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+ 1
+
+
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+ 1
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+ 0
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+
+
+
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+ 1
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+
+
nucleic acid substance
single substance that can be defined by a linear sequence of nucleosides typically linked through phosphate or phosphate-like diester bonds
+ Nucleic acids are defined by three distinct elements: the base, sugar and linkage. Individual substance/moiety IDs will be created for each of these elements. The nucleotide sequence will be always entered in the 5'-3' direction. The nucleic acid set of elements are only to be used to describe nucleic acids that have:
+— A length greater than three bases or base pairs;
+— Elements to be used for oligonucleotides;
+— Genes used in gene therapy;
+— Any nucleic acid aptamers.
+For the description of nucleic acids, the following information can be used to assign Substance IDs:
+— Nucleotide Sequence;
+— Sugar or sugar-like entities;
+— Linkage (typically phosphate);
+— Nucleic Acid Type (RNA, DNA, plasmid, single or double stranded);
+— Any Modifications to the substance either sequence specific (i.e. modified or unnatural base, sugar, phosphate linkage) or non-sequence specific modifications.
+ The sequence of the nucleic acid, the type (RNA, DNA, plasmid, single or double stranded), sugar or sugar-like entities, linkage (typically phosphate), together with any modifications that affect the molecular structure, shall be the defining elements for nucleic acid substances.
The type of nucleic acid substance, e.g. ribonucleic acid (RNA) and deoxyribonucleic acid (DNA), is also identified. Oligonucleotides and gene elements, e.g. promoters, enhancers, coding sequences and silencers, are defined as nucleic acid substances.
- ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.2.1 and Figure 5
- ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.54
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clauses 6.2.1 and 7.3 and Figures 5 and 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clauses 3.54, 7.5
+
+
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ 1
+
+
+
+
+
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+ 0
+
+
+
+
+
+
+ 0
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+ 1
+
+
+ nucleic acid subunit
+ constituent of a nucleic acid
+ Subunits are listed in order of decreasing length; sequences of the same length will be ordered by molecular weight; subunits that have identical sequences will be repeated multiple times.
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clauses 6.2.1 and 7.3 and Figures 5 and 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clauses 3.54, 7.5
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ nucleotide sequence type
+ classifier that indicates the nature of the nucleotide sequence
+ complete, partial
+
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+ sequence type
+ No controlled vocabulary or code list is defined in either ISO 11238 or the ISO/TS 19844 implementation guide.
@@ -2277,6 +2520,75 @@
Superseded
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ oligo nucleotide type
+ classifier that distinguishes a single stranded oligo nucleotide from a double stranded gene or rDNA vaccine
+ Single-stranded DNA; Double-stranded DNA
+
+ Single-stranded DNA; Double-stranded DNA; Single-stranded RNA; Double-stranded RNA
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ oligo nucleotide type - double-stranded DNA
+ classifier for an oligo nucleotide indicating that it is a double-stranded DNA
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+ Double-stranded DNA
+
+
+
+
+ oligo nucleotide type - double-stranded RNA
+ classifier for an oligo nucleotide indicating that it is a double-stranded RNA
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+ Double-stranded RNA
+
+
+
+
+ oligo nucleotide type - single-stranded DNA
+ classifier for an oligo nucleotide indicating that it is a single-stranded DNA
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+ Single-stranded DNA
+
+
+
+
+ oligo nucleotide type - single-stranded RNA
+ classifier for an oligo nucleotide indicating that it is a single-stranded RNA
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+ Single-stranded RNA
+
+
@@ -5260,6 +5572,47 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.6.4.3
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+ 1
+
+
+
+
+
+
+ 1
+
+
+ sugar
+ short chain carbohydrate molecule that has hydroxyl groups attached to each carbon atom unit with the exception of one carbon that has a doubly-bond aldehyde or ketone oxygen
+ As a chemical term, 'sugar' typically refers to carbohydrates of the general formula Cn(H2O)n.
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ Medical Subject Headings (MeSH, see http://purl.bioontology.org/ontology/MESH/D000073893
+ In the context of the ISO 11238 standard, the term 'sugar' is used to mean 'sugar or sugar-like entity'.
+
+
@@ -5393,6 +5746,19 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clauses 6.8.1
+
+
+ has area of hybridization
+
+ provides a textual specification for an area of hybridization, if applicable, for double stranded RNA or DNA
+ Each residue shall be specified followed by a comma and space.
+ The number associated with the subunit followed by the number associated to the residue shall be specified in increasing order. The underscore '_' shall be used as separator as follows: 'Subunit_number Residue'.
+
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has atomic number
@@ -5555,6 +5921,43 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
indicates any arrangement and/or organization of interrelated elements in a specification for a substance
+
+
+ has five prime substance identifier
+
+
+
+
+
+
+
+
+
+
+ relates a nucleic acid subunit to the unique identifier of the five prime
+ JKUHT76541 (Artificial ID)
+
+ ISO 11238 Substance ID
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ has five prime substance name
+
+ relates a nucleic acid subunit to the nucleotide present at the 5' terminal
+ Tymidine (T)
+ The nucleotide present at the 5' terminal should be specified based on a controlled vocabulary. Since the sequence is represented from the 5' to the 3'end, the 5' prime nucleotide is the letter at the first position in the sequence. A separate representation would be redundant.
+ Implicit. If not specified in the available reference source this value shall be derived from the nucleic acid sequence.
+
+ ISO 11238 Substance Name
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has granular molecular part
@@ -5690,6 +6093,54 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.7.7.3
+
+
+ has linkage connectivity
+
+ provides a textual indication of the orientation of the linkage
+ For nearly all naturally occurring nucleic acids the linkage is a phosphate group. For many synthetic oligonucleotides phosphorothioate linkages are often seen. Linkage connectivity is assumed to be 3’→5’. If the linkage is either 3’→3’ or 5’→5’ this should be specified.
+
+ 3’→5’, 3’→3’ or 5’→5’
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ has linkage identifier
+
+
+
+
+
+
+
+
+
+
+ relates an interconnection (linkage), registered as a fragment, to its unique substance identifier
+
+ ISO 11238 Substance ID
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ has linkage name
+
+ relates an interconnection (linkage), registered as a fragment, to its registered name
+ Phosphothioate
+ A single name should be assigned to each linkage.
+
+ ISO 11238 Substance Name
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has mass number
@@ -5912,6 +6363,20 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
has an amount expressed as non-numeric value
+
+
+ has nucleotide sequence
+
+ specifies the actual nucleotide sequence notation from 5' to 3' end using standard single letter codes
+ GATTCA
+ In addition to the base sequence, sugar and type of phosphate or non-phosphate linkage should also be captured.
+
+ Sequence of the letters G, C, T, A, and U
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has nuclide name
@@ -5943,6 +6408,23 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
+
+
+
+ has number of subunits
+
+
+ indicates the number of linear sequences of nucleotides linked through phosphodiester bonds
+ 1, 2, or 3
+ If not specified in the reference source, the assumption is that there is 1 subunit.
+ Subunits would be strands of nucleic acids that are tightly associated typically through Watson-Crick base pairing.
+ This number is implicit and derived from number of nucleic acid subunits.
+
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has official name status change date
@@ -5997,7 +6479,7 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
-
+
has parent substance
ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.3.1
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.6.3
@@ -6146,14 +6628,14 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
-
+
- relates a substance relationship to the substance, moiety, or physical substance that is the target of the relationship
+ relates something, such as a substance relationship, to the substance, moiety, or matter, including a molecular entity or physical substance that is the target of the relationship
ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.2.4 and Figure 16
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.6 and Figure 8
@@ -6167,7 +6649,7 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
- relates a substance that is the target in a substance relationship relationship to an identifier for that substance, moiety, or physical substance
+ relates a substance that is the target of something, such as a substance relationship, to an identifier for that substance, moiety, or matter
ISO 11238 Substance ID
@@ -6183,7 +6665,7 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
- relates a substance that is the target in a substance relationship relationship to a preferred term or primary name for that substance, moiety, or physical substance
+ relates a substance that is the target of something, such as a substance relationship, to a preferred term or primary name for that substance, moiety, or matter
The preferred term of the related substance is captured; this information is required when there is a 'Substance Relationship'; The substance name is implicit and derived from the Substance ID.
Based on ISO 11238 substance name
@@ -6224,6 +6706,19 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
It may be known that lysine residues are modified but the particular lysine in the sequence may not be known. It should be captured for both specific and non-specific modifications, e.g. sizing carbohydrate polymers by hydrolysis.
+
+
+ has residue site
+
+ describes the residues that contain a given sugar entity
+ 1_1-1_20 would indicate that residues 1-20 of a given strand contain a particular sugar.
+ The residues that contain a given sugar shall be captured. The order of given residues will be captured in the 5'-3' direction consistent with the base sequences.
+
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has SMILES
@@ -6249,6 +6744,32 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
has simplified molecular input line entry specification value
+
+
+ has sequence attachment
+
+ provides an 'enriched' string, a document or image representing the sequence
+ The element Sequence is always mandatory; the element Sequence Attachment may be provided based on jurisdictional guidance. Either the sequence is provided as ST or/and as an attachment as ED.
+
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ has sequence length
+
+
+ indicates the length of a particular linear sequence
+ 5
+ The sequence length is implicitly derived by the sequence description.
+
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
@@ -6439,6 +6960,58 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
+
+
+
+ has subunit index
+
+
+ indicates the index (ordering) of a particular linear sequence
+ 1, 2, 3 (..)
+ Sequences are ordered by decreasing length. Sequences of the same length will be ordered by molecular weight. Subunits that have identical sequences will be repeated and have sequential subscripts.
+
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ has sugar identifier
+
+
+
+
+
+
+
+
+
+
+ indicates the unique substance identifier for the sugar or sugar-like component that makes up the nucleotide
+ UNII code for ribose
+ For naturally occurring nucleic acids the sugar is typically either .beta.-D-ribose or .beta.-D-deoxyribose. The actual configuration of the sugar shall be captured.
+
+ ISO 11238 Substance ID
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ has sugar name
+
+ indicates the name of the sugar or sugar-like component that makes up the nucleotide
+ Ribose, deoxyribose, 2,5-dihydroxy-morphilino
+ This is implicit and derived from the Sugar ID. The preferred name is the default value.
+
+ ISO 11238 Substance Name
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has target identifier
@@ -6492,11 +7065,58 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.6.4.6 and Figure 8
+
+
+ has three prime substance identifier
+
+
+
+
+
+
+
+
+
+
+ relates a nucleic acid subunit to the unique identifier of the three prime
+ JKUHT76541 (Artificial ID)
+
+ ISO 11238 Substance ID
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ has three prime substance name
+
+ relates a nucleic acid subunit to the nucleotide present at the 3' terminal
+ Thymine (T)
+ The nucleotide present at the 3’ terminal should be specified based on a controlled vocabulary. Since the sequence is represented from the 5' to the 3' end, the 5’ prime nucleotide is the letter at the last position in the sequence. A separate representation would be redundant.
+ NOTE If not specified in the available reference source this value is derived from the nucleic acid sequence.
+
+ ISO 11238 Substance Name
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
has values allowed
describes the nature of valid values for a given class or element in cases where that information is encoded as a string rather than as a value domain per the ISO 19844 guideline
+
+
+ interconnects
+
+ relates a linkage, bridge, or connecting element to something, such as a nucleic acid subunit, that it connects
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
is active moiety of
@@ -6541,6 +7161,15 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
relates an ingredient to a substance or product composition that it is included in
+
+
+ is interconnected via
+ relates something, such as a nucleic acid subunit, to something that connects it to something else
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
is moiety of
@@ -6619,9 +7248,20 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
is related substance to
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.6.3
-
-
- specifies a target substance with which the source has some relationship
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+
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+ specifies something, possibly a target substance, moiety, or matter with which the source substance, moiety, or matter has some relationship
The active moiety of the salt amlodipine besilate hydrate (1:1:1) is the related substance amlodipine. The salt amlodipine besilate hydrate contains 69.8 percent w/w of amlodipine. Therefore, the equivalence factor is 0,698, meaning 10 mg amlodipine besilate hydrate salt corresponds to 6,98 (approx to 7 mg) amlodipine active moiety. The Equivalence Factor is captured by the element group Amount in combination with the element group Substance Relationship as Amount Text.
Relationships between substances such as the relationship between a salt form and its active moiety or parent substance should be captured. These relationships are often essential to the description of medicinal products, the basis of strength and the classification of substances. These relationships are often obvious and rules will be developed for specifying substances involved in each type of relationship. For example, the active moiety of all sodium salts would be the free acid, conversely the active moiety of a hydrochloride salt would be a free base.
The Equivalence Factor shall be less than or equal to 1,00. It is formed by dividing the molecular weight of the (parent) substance (active moiety)/molecular weight of the corresponding salt or salt hydrate or hydrate.
@@ -6654,6 +7294,25 @@ In all these cases, a new ID shall be issued, that is, 'Human Albumin, Plas
ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause 6.6 and Figure 8
+
+
+ is supported by
+ relates something, such as a nucleic acid subunit, to a substance, moiety or matter that supports it
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+
+
+
+ supports
+
+ relates a substance, moiety or matter to something, such as a nucleic acid subunit, that it enables
+
+ ISO/TS 19844:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances, clause and 7.3 and Figure 27
+ ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 7.5
+
+