IDMP Wiki

ISO

ISO ist the short form of the International Organization for Standardization. It is an international standard-setting body composed of representatives from various national standards organizations.

Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is headquartered in Geneva, Switzerland, and as of 2013 works in 164 countries.

IDMP Wiki

ISO 11238

Regulated information on substances (ISO 11238)
ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade). Substances can have different roles in medicinal products (e.g. active, adjuvant). They are identified via their molecular weight, structure and their unique Identification Number (ID).

Synonym and Abbreviations for Amlodipin (as example):
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester (IUPAC)
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate (WHO)
AMLODIPIINI
Amlodipin (ABDATA-SK)
Amlodipin (ABDATA-SK;ASK;INN.L25.D)
AMLODIPINA
AMLODIPINĂ
AMLODIPINAS
Amlodipine (BAN1999;DCF;INN.L25.E;INN.L25.F)
Amlodipino (INN.L25.S)
AMLODIPĪNS
Amlodipinum (INN.L25.L)
AMLODYPINA
ΑΜΛΟΔΙΠΊΝΗ
ΑΜΛΟΔΙΠΊΝΗΣ
АМЛОДИПИН

Synonym Details:

Term Lang Role Code Type Source
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester N/A SY 1134301 SUB ABDATA
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate N/A SY 1134301 SUB ABDATA
AMLODIPIINI FI ST SUB05467MIG SUB EMA
Amlodipin DE ST C08CA01 ATC WHO
Amlodipin N/A PT 1134301 SUB ABDATA
Amlodipin DA ST SUB05467MIG SUB EMA
Amlodipin HR ST SUB05467MIG SUB EMA
Amlodipin HU ST SUB05467MIG SUB EMA
Amlodipin SK ST SUB05467MIG SUB EMA
Amlodipin SL ST SUB05467MIG SUB EMA
AMLODIPINA ES ST SUB05467MIG SUB EMA
AMLODIPINA IT ST SUB05467MIG SUB EMA
AMLODIPINĂ RO ST SUB05467MIG SUB EMA
AMLODIPINAS LT ST SUB05467MIG SUB EMA
Amlodipine N/A PT SUB05467MIG SUB EMA
Amlodipine FR ST SUB05467MIG SUB EMA
Amlodipine N/A SY 1134301 SUB ABDATA
Amlodipine EN PT 1J444QC288 SUB FDA
Amlodipine EN PT C08CA01 ATC WHO
Amlodipino N/A SY 1134301 SUB ABDATA
Amlodipino ES ST SUB05467MIG SUB EMA
AMLODIPĪNS LV ST SUB05467MIG SUB EMA
Amlodipinum CS ST SUB05467MIG SUB EMA
Amlodipinum LA ST SUB05467MIG SUB EMA
Amlodipinum N/A SY 1134301 SUB ABDATA
AMLODYPINA PL ST SUB05467MIG SUB EMA
ΑΜΛΟΔΙΠΊΝΗ EL ST SUB05467MIG SUB EMA
ΑΜΛΟΔΙΠΊΝΗΣ EL ST SUB05467MIG SUB EMA
АМЛОДИПИН BG ST SUB05467MIG SUB EMA

Other Properties:

Type Code Descr
ATC C08CA01 Calcium channel blockers
Selective calcium channel blockers with mainly vascular effects
Dihydropyridine derivatives
Amlodipine
Contributing Source ABDATA WHO FDA FDB EMA
Semantic Type SUB ATC
CAS-Registry Number 88150-42-9
Molecular formula C20H25ClN2O5
Molecular weight 408,88

Synonym and Abbreviations:
Amlodipin benzolsulfonat (1:1)
Amlodipine besilate (BAN1999;BP)
Amlodipine besylate (USAN;USP)
Amlodipini besilas

Weblinks:
Visit the IDMP Term Browser® with ISO 11238 data on Amlodipine Besilate in idmp1 (access restricted to registered users of the IDMP Term Browser®)

IDMP Wiki

ISO 11239

ISO 11239 IDMP Standard lists regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.

The ISO 11239 standard identifies for example injection solution, injection suspension, infusion solution (or a less granular regional term linked to these.

Differences in granularity between regional terminologies
Many of the concepts covered in ISO 11239 are already described in various regions using their own sets of terminologies, which are usually not harmonised with those of other regions. This is often because of different levels of granularity between regions, which means that one-to-one mapping between those regions’ terms is not possible. For example, if the terms used in region A have a relatively low level of granularity compared to the terms used in region B, one term from region A will often map to several terms from region B. Indeed, the purpose of ISO 11239 is to allow for the development of a single set of controlled vocabularies that can be used by all regions to communicate with each other, and to which all regions can map their own regional terms.

The figure gives an example of how terms from Europe, the US and Japan might map to a list of central terms.

In this example:

  •  central terms distinguish between injection and infusion products but not between lyophilised and non-lyophilised powders;
  • Europe distinguishes between injection and infusion products but not between lyophilised and non-lyophilised powders (i.e. the same as the central terms);
  • the US distinguishes between lyophilised and non-lyophilised powders but not between injection and infusion products;
  • Japan uses a single term to describe all injection and infusion products.

As a result, with respect to the central terms there is one-to-one mapping for each European term, there is one-to-two mapping for each US term, and there is one-to-many mapping for the Japanese term.

 

iso 11239 mapping terms

iso-11239-mapping-terms

ISO 11239 Screen from the IDMP Term Browser® for “capsule”:

Synonym and Abbreviations:

Kapsel
Kapsula
Kapsulė
Kapsulë
Капсула
Капсули

Synonym Details:

Term Lang Role Code Type Source
Capsule EN PT 12100 SYN EDQM
Capsule EN PT C25158 PHF FDA
Capsule EN PT PHF00005MIG PHF EMA
Kapsel ET ST 12100 SYN EDQM
Kapsula SR ST 12100 SYN EDQM
Kapsulė LT ST 12100 SYN EDQM
Kapsulë SQ ST 12100 SYN EDQM
Капсула KK ST 12100 SYN EDQM
Капсули UK ST 12100 SYN EDQM

Other Properties:

Type Code Descr
Contributing Source EDQM FDA EMA
Semantic Type SYN PHF PAC PRE

 

IDMP Wiki

ISO 11240

ISO 11240 – Units of Measurement

What ISO 11240 does:

  • specifies rules for the usage of units of measurement for IDMP
  • specifies requirements for traceability to metrological standards
  • establish reference code system for units
  • provide structures and rules for mapping between different unit vocabularies and language translations
  • linking to existing systems, dictionaries, and repositories

Strength of a medicinal product based on ISO 11240

In the case of strength given on a per dose basis, additional information on the characteristics of the countable dose item
may be required when comparing to strengths of other products.

EXAMPLE 1 Expression “per dose”: Total amount of substance per total amount of solution (200 mg of substance
contained in 10 ml of solution), total mass of ingredient contained in one single dose (500 mg of substance contained in
one tablet). Note that the description of the component (substance, solution, tablet) is not part of the unit of measurement.

EXAMPLE 2 Expression as intensive quantity: Mass concentration 20 mg/ml, activity content 5,000 IU/g.

EXAMPLE 3 Using the unit symbol “U”
The unit “U” of enzymatic activity was defined in 1964 by the International Union of Biochemistry as the
catalytic activity that catalyses the transformation of 1 µmol of the substrate per minute. Typical biological
enzyme activities are in the range of 1 U to 100 U. This unit of measurement can also be expressed explicitly
as “µmol/min”, where enzymatic activity is the property being addressed. Still, some arbitrariness is involved in
the definition of “standard conditions” (e.g. temperature, pH).

This unit denoted by the symbol “U” is not an arbitrary unit. In order to ensure traceability and avoid ambiguities,
it is important to discriminate this meaning against the frequently encountered usage of the same symbol “U”
for other (arbitrary) units. This is especially required to ensure unique meaning of codes used for information
exchange. “U” is assigned to enzymatic activity in the UCUM code system. However, the following description
uses the symbol “U” for a completely unrelated concept. Here “U” stands for an arbitrary unit that is defined
based on a “bioassay”:

e.g. Concentration 5 000 U/ml solution for injection.

Mapping between different unit vocabularies and language translations

ISO 11240 mapping table

ISO 11240 mapping table

IDMP Wiki

ISO 11615

ISO 11615 establishes definitions and concepts required for the detailed description and unique identification of medicinal products.

The scope of ISO 11615

ISO 11615 describes data elements and regulated medicinal product information during their entire life cycle (development, authorisation, post-marketing and renewal or withdrawal from the market) and is composed of several ISO Standards.
Taken together all ISO IDMP standards (EN ISO 11615/DTS 20443, EN ISO 11616/DTS 20451, EN ISO 11238/DTS 19844, EN ISO 11239/DTS 20440 and EN ISO 11240) define, characterize and uniquely identify regulated medicinal products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterization of medicinal products, the use of HL7 Common Product Model and Structured Product Labeling (SPL) messaging aspects is also described.
In addition, reference to the use of other normative IDMP and messaging standards for Medicinal Product information is included in this Technical Specification in order to support successful related information exchange.

Information for an authorized medicinal product

ISO 11615 describes the main concepts modelled to identify a medicinal product.

ISO 11615 model

ISO 11615 model

 

ISO Standards included in ISO 11615

The following normative standards are essential components for successful implementation of the exchange of IDMP data elements:

  • EN ISO 11615:2012, Health Informatics -Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information
  • EN ISO11616:2012, Health informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
  • EN ISO 11238:2012, Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated information on substances
  • EN ISO 11239:2012, Health Informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
  • EN ISO 11240:2012, Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of units of measurement