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CD-precise concepts shall be modeled using the proximal primitive modeling pattern.CD CD-precise concepts representing continuous dose form (e.g., solutions, suspensions, creams, ointments, patches) will will be modeled using concentration strength attributes; presentation strength attributes are not allowed for these concepts in the International Release.Example:
For example,
- Product containing precisely zidovudine 10 milligram/1 milliliter conventional release oral solution (clinical drug)
- Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
- Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
- Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)
- Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)
The following exceptions have been identified.
- Concepts with product strength that is "not equal to"
- These concepts will be modeled as primitive, with attributes added as described in the following sections, except that strength numerator attributes will not be added.
- These concepts will have the appropriate Medicinal Product Form-only (MPF-only) concept as an inferred parent.
For solids and semi-solids, a concentration strength will be mass/mass (w/w) – usually mg/g.
For liquids, a concentration strength will be mass/volume (w/v) – usually mg/mL.
For clinical drugs that are different to the above, submitters need to give a clear justification for the variance.
Stated parent concept | 763158003 |Medicinal product (product) | ||||
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Semantic tag | (clinical drug) | ||||
Definition status | 900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)| Exceptions:
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Attribute: Has manufactured dose form | Range: 736542009 |Pharmaceutical dose form (dose form)
Cardinality: 1..1 The attribute value should represent the manufactured dose form Notes: 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)|) | ||||
Attribute: Count of base of active ingredient (attribute) | Concrete Type: Integer Range: >#0.. Cardinality: 1..1 | ||||
Relationship group | One relationship group containing one instance of each of the following attributes is required for each 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:
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| Range: 105590001 |Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group | ||||
| 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:
To avoid semantically equivalent concepts, product strength for units are normalized as follows:
The following units are not allowed unless specifically noted as an exception:
Repeating decimals are rounded to three decimal places (with 5 and above rounded up and 4 and below rounded down). | ||||
| Range: 767524001 |Unit of measure (qualifier value)| - descendants only Cardinality: 1..1 per relationship group | ||||
| 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 though the value = 1 because including denominators for only some concepts negatively affects the classification results. | ||||
| Range: 767524001 |Unit of measure (qualifier value)| - descendants only Cardinality: 1..1 per relationship group
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