Overview
Clinical drugs representing a continuous dose form are modeled using concentration strength attributes. Clinical drugs with a continuous dose form using concentration strength represents a medicinal product based on description of 1) its precise active ingredient substances only and explicitly, 2) the stated basis of strength substance(s) with strength, expressed as concentration strength and 3) with its manufactured dose form (with the exception of reconstituted oral liquid preparations, where the administrable dose form is be used as it is the most clinically relevant).
This is used for product types such as cutaneous semi-solids (without metered actuation), solutions, suspensions, creams, ointments, bulk powders and granules, topical liquids (without metered actuation) including drops, oral liquids, nebuliser liquids and liquid parenteral products.
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)
Modeling
Stated parent | 763158003 |Medicinal product (product)| |
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Semantic tag | (clinical drug) |
Definition status | Defined Exception:
|
Attribute: Has manufactured dose form | Range: 736542009 |Pharmaceutical dose form (dose form)|
Cardinality: 1..1 Note
Powder and granules for oral suspension, solution, etc., may be modeled using concentration strength and the administrable dose form. For example,
|
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) excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group
|
| Range: <105590001 |Substance (substance) 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 |
| Range: <767524001 |Unit of measure (qualifier value)| 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 1. 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)| Cardinality: 1..1 per relationship group For Clinical drug concepts with:
|
Naming
Use one of the following patterns for the FSN and PT.
FSN | Where Precise active ingredient = BoSS:
For example,
Where Precise active ingredient is not = BoSS:
For example,
|
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Preferred Term | Where Single ingredient with BoSS = Precise active ingredient:
For example,
Where Single ingredient with BoSS is not = Precise active ingredient:
For example,
|
Synonyms | Synonyms converting metric units to percent or parts per millions may be included for medical gas concepts (e.g. Helium 79% and oxygen 21% gas for inhalation, Helium 790,000 ppm and oxygen 210,000 ppm gas for inhalation). |
Exemplars
Stated template view:
The following illustrates the stated view for 781834001 |Product containing precisely digoxin 250 microgram/1 milliliter conventional release solution for injection (clinical drug)|:
The following illustrates the inferred view for 781834001 |Product containing precisely digoxin 250 microgram/1 milliliter conventional release solution for injection (clinical drug)|:
The following illustrates the stated view for 769821007 |Product containing precisely digoxin 50 microgram/1 milliliter conventional release oral solution (clinical drug)|:
The following illustrates the inferred view for 769821007 |Product containing precisely digoxin 50 microgram/1 milliliter conventional release oral solution (clinical drug)|:
The following illustrates the stated view for 396279000 |Product containing precisely betamethasone (as betamethasone valerate) 1 milligram/1 gram conventional release cutaneous ointment (clinical drug)|:
The following illustrates the inferred view for 396279000 |Product containing precisely betamethasone (as betamethasone valerate) 1 milligram/1 gram conventional release cutaneous ointment (clinical drug)|:
The following illustrates the stated view for 769514000 |Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)|:
The following illustrates the inferred view for 769514000 |Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)|:
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