Overview
CD-precise concepts Clinical drugs representing continuous dose form (e.g., solutions, suspensions, creams, ointments, patches) are modeled using concentration strength attributes; presentation strength attributes are not allowed for these concepts in the International Release.
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- 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)
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Modeling
| Stated parent | concept | 763158003 |Medicinal product (product)| |
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| Semantic tag | (clinical drug) |
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| Definition status | Defined ExceptionsException: - Concepts with product strength that is "not equal to" (e.g. with product strength expressed as a range, greater than, or less than) are primitive
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Attribute: Has manufactured dose form | Range: 736542009 |Pharmaceutical dose form (dose form)| - While the allowed range for this attribute is broader, the CD-precise continuous dose from concepts should only use <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 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)|) |
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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) excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group - The Precise Active Ingredient (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) excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group |
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- Has concentration strength numerator value
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group |
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- Has concentration strength numerator unit
| Range: <767524001 |Unit of measure (qualifier value)| Cardinality: 1..1 per relationship group |
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- Has concentration strength denominator value
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group For this pattern, the attribute value must be 1. Note: the The denominator strength value is required for concepts in the the International Release even though the value = 1, because including denominators for only some concepts negatively affects the classification results. |
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- Has concentration strength denominator unit
| Range: <767524001 |Unit of measure (qualifier value)| Cardinality: 1..1 per relationship group
For Clinical drug concepts with: - liquid dose form: the denominator unit should be 258773002 |Milliliter (qualifier value)|.
- semi-solid dose form: the denominator unit should be
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| t | 258682000 |gram (qualifier value)| |
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for weight/weight concentration and 258773002 |Milliliter (qualifier value)| for weight/volume concentration. Representing semi-solid dose forms in weight/weight concentration is preferred.
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Naming
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Use one of the following patterns for the FSN and PT.
| FSN | Where Precise active ingredient = BoSS: - Product containing precisely <BoSS FSN> <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)
For example, - Product containing precisely amitriptyline hydrochloride 5 milligram/1 milliliter conventional release oral solution (clinical drug)
- Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)
- Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
- Product containing precisely zidovudine 10 milligram/1 milliliter conventional release oral solution (clinical drug)
- Product containing precisely lopinavir 80 milligram/1 milliliter and ritonavir 20 milligram/1 milliliter conventional release oral solution (clinical drug)
Where Precise active ingredient is not = BoSS: - Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)
For example, - Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
- Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)
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| Preferred Term | Use one of the following patterns for the PT. | Where Single ingredient with BoSS = Precise active ingredient: - <BoSS PT> <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>
For example, - Amitriptyline hydrochloride 5 mg/mL oral solution
- Buprenorphine 70 microgram/hour prolonged-release transdermal patch
- Clotrimazole 10 mg/g cutaneous cream
- Zidovudine 10 mg/mL oral solution
- Lopinavir 80 mg/mL and ritonavir 20 mg/mL oral solution
Where Single ingredient with BoSS is not = Precise active ingredient: - <BoSS PT> (as <Precise active ingredient PT>) <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>
For example, - Amikacin (as amikacin sulfate) 250 mg/mL solution for injection
- Mupirocin (as mupirocin calcium) 20 mg/g nasal ointment
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| 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). |
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