Editorial guidelines for the 736542009 | Pharmaceutical dose form (dose form)| hierarchy and for supporting hierarchies required to support creation of sufficiently defined pharmaceutical dose form concepts are documented in the following pages.
General Assumptions and Requirements
Concept model will include attributes necessary to define the concepts to ensure consistent and reproducible modeling of concepts, whose use is primarily to describe or group concepts in the 763158003 | Medicinal product (product)| hierarchy.
Any requirement to align to external standards or registries will be explicitly documented.
Concept model will be compatible with the following ISO (International Organization for Standardization) IDMP (Identification of Medicinal Products) standards where appropriate:
- ISO 11239 Health informatics, 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
- ISO/TS 20440 Health informatics, Implementation guide for ISO 11239 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
Concepts in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy:
- shall be sufficiently defined using proximal primitive modeling methodology unless explicitly noted as an exception in the editorial guidelines,
- is not intended to eliminate the need for a national extension.
Out of Scope
- Concepts representing combined dose forms (e.g. single concepts describing the multiple dose forms found in kit products such as cream and pessary)
- Concepts in pattern "x for y for z" (e.g. Powder for concentrate for dispersion for infusion)
- Concepts representing proprietary dose forms
Concepts that are not allowed to be used in modeling Medicinal product concepts in the International Release may be added to the Pharmaceutical dose form hierarchy to support national extension modeling.
For example,
- 420378007 |Prolonged-release film-coated oral tablet (dose form)|)
Overview
The 736542009 |Pharmaceutical dose form (dose form)| hierarchy is comprised of the types of concepts as shown in the table below. Detailed editorial guidelines for each distinct concept type, including required attributes and naming guidelines, are found in the sections that follow.
For the purposes of the following editorial guidelines, pharmaceutical dose form refers to the physical manifestation of a medicinal product that contains the active ingredient substance(s) and inactive ingredient substances that are intended for administration for the patient.
Concept type | Examples |
|---|---|
| Grouper based on intended site |
|
| Grouper concept without basic dose form |
|
| Pharmaceutical dose form |
|
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