| Stated parent concept | 763158003 |Medicinal product (product) |
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| Semantic tag | (clinical drug) |
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| Definition status | 900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)| - Exceptions:
- Concepts with product strength that is "not equal to" (e.g. with product strength expressed as a range, greater than, or less than) will have definition status 900000000000074008 |Necessary but not sufficient concept definition status (core metadata concept)|.
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Attribute: Has manufactured dose form | Range: 736542009 |Pharmaceutical dose form (dose form) - descendants only - NOTE: While the allowed range for this attribute is broader, the CD-precise discrete dose form concepts should only use descendants of 736542009 |Pharmaceutical dose form (dose form), excluding grouper concepts based on intended site (e.g. 740596000 |Cutaneous dose form (dose form)|, 385268001 |Oral dose form (dose form)|)
Cardinality: 1..1 The attribute value should represent the manufactured dose form. Notes: - Concepts with dose form of drops or spray will be modeled in the International Release with Pharmaceutical dose form concepts that do not specify the basic dose form (e.g. 385018001 |Conventional release oral drops (dose form)| or 385073003 |Conventional release oromucosal spray (dose form)|).
- More specific Pharmaceutical dose form concepts (e.g. 385019009 |Conventional release solution for oral drops (dose form)| or 761905004 |Conventional release solution for oromucosal spray (dose form)|) will be retained in the International Release but will not be used for modeling Clinical drug concepts; they can be used for modeling in national extensions.
- Powder and granules for oral suspension, solution, etc. may be modeled using concentration strength and the administrable dose form (e.g. 1145409004 |Product containing precisely amoxicillin 25 milligram/1 milliliter and clavulanic acid (as clavulanate potassium) 6.25 milligram/1 milliliter conventional release oral suspension (clinical drug)|)
- Clinical drug concepts in the International Release should not be modeled using dose forms for “lyophilized powder” because it is not a clinically relevant distinction at the Clinical drug level.
- Pharmaceutical dose forms referring to “lyophilized powder” will be retained in the International Release but will not be used for modeling Clinical drug concepts; they can be used for modeling in national extensions.
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Attribute: Has unit of presentation | Range: 732935002 |Unit of presentation (unit of presentation)| - descendants only Cardinality: 1..1 |
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Attribute: Count of base of active ingredient (attribute) | Concrete Type: Integer Range: >#0.. Cardinality: 1..1 |
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| Relationship group | One relationship group containing one instance of each of the following attributes is required for each precise active ingredient. |
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- Has precise active ingredient
| Range: 105590001 |Substance (substance)| - descendants only, excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group Notes: - The PAI cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a hydrate or solvate.
- Concepts containing pancreatic enzymes will be modeled based on the discrete enzymes; because of variability between real clinical drugs, synonyms representing a total amount in a particular product will not be included in the International Release.
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- Has basis of strength substance
| - Range: 105590001 |Substance (substance)| - descendants only, excluding concepts representing structural groupers, dispositions, or combined substances
- Cardinality: 1..1 per relationship group
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- Has presentation strength numerator value
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group Expression of product strength in metric units is preferred. To avoid semantically equivalent concepts, product strength for metric units are normalized as follows: - Use milligram if value is <1000; if > then convert to gram
- Use microgram if value is <1000; if > then convert to milligram
- Use nanogram if value is <1000; if > then convert to microgram
- Use picogram if value is <1000; if > then convert to nanogram
To avoid semantically equivalent concepts, product strength for units are normalized as follows: - Use million unit if value is >1000000 unit
The following units are not allowed unless specifically noted as an exception: - 408165007 |Mega u (qualifier value)|
Repeating decimals are rounded to three decimal places (with 5 and above rounded up and 4 and below rounded down). |
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- Has presentation strength numerator unit
| Range: 767524001 |Unit of measure (qualifier value)| - descendants only Cardinality: 1..1 per relationship group |
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- Has presentation strength denominator value
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group For this pattern the attribute value must be 38112003 |1 (qualifier value)| Note: the denominator strength value is required for concepts in the International Release even if the value = 1 because including denominators for only some concepts negatively affects the classification results. |
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- Has presentation strength denominator unit
| - Range: 767524001 |Unit of measure (qualifier value)| - descendants only
- While the allowed range for this attribute is broader, the CD-precise concepts representing discrete dose forms should only use descendants of 732935002 |Unit of presentation (unit of presentation).
- Cardinality: 1..1 per relationship group
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