Overview
The following modeling and terming guidelines apply to concepts in the International Release; editorial guidelines for concepts in national extensions will be documented separately.
The Clinical Drug "containing precisely" (CD) concept is an abstract representation of the precise active ingredient(s), BoSS, strength, and pharmaceutical dose form for a medicinal product. It means that the medicinal product must contain only the precise active ingredient(s) specified in the FSN.
Example:
- Product containing precisely abacavir 300 milligram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely abacavir 300 milligram and lamivudine 150 milligram and zidovudine 300 milligram/1 each conventional release oral tablet (clinical drug)
Modeling
CD concepts representing discrete solid dose forms shall be modeled using the proximal primitive modeling pattern.
Exceptions: none identified
| Stated parent concept | 763158003|Medicinal product (product) - Exceptions: none identified
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| Semantic tag | (clinical drug) |
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| Definition status | 900000000000073002 | Sufficiently defined concept definition status (core metadata concept) - Exceptions: none identified
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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 Clinical Drug - Discrete Solid 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)|).
- Exceptions: none identified
- Cardinality: 1..1
- Attribute value must represent the manufactured dose form
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Attribute: Has unit of presentation | - Range: 732935002 | Unit of presentation (unit of presentation) - descendants only
- Exceptions: none identified
- Cardinality: 1..1
- Attribute value must represent the basic manufactured dose form
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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, roles, and combined substances
- Cardinality: 1..1 per relationship group
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- |Has basis of strength substance|
| - Range: 105590001|Substance (substance) - descendants only, excluding concepts representing structural groupers, dispositions, roles, and combined substances
- Cardinality: 1..1 per relationship group
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- |Has presentation strength numerator value|
| - Range: 260299005|Number (qualifier value)
- Cardinality: 1..1 per relationship group
Product strength normalization for metric units: - Use picogram if value is <1000; if if > then convert to nanogram
- Use nanogram if value is <1000; if > then convert to microgram
- Use microgram if value is <1000; if > then convert to milligram
- Use milligram if value is <1000; if > then convert to gram
Product strength normalization for units: - 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)|
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- |Has presentation strength numerator unit|
| - Range: 258666001|Unit (qualifier value) - descendants only
- Cardinality: 1..1 per relationship group
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- |Has presentation strength denominator value|
| - Range: 260299005|Number (qualifier value)
- 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: 732935002|Unit of presentation (unit of presentation) - descendants only
- NOTE: While the allowed range for this attribute is broader, the Clinical Drug - Discrete Solid Dose Form concepts should only use descendants of 732935002|Unit of presentation (unit of presentation).
- Exceptions: none identified
- Cardinality: 1..1 per relationship group
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Terming
| FSN | Use the following pattern for the FSN; align terming and case sensitivity with the FSN for the concepts that are selected as the attribute value. For multiple ingredient drug products, the BoSS must be in alphabetical order and separated by the word “and”. Single ingredient with BoSS = Precise active ingredient: - Product containing precisely <BoSS FSN> <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/1 each <Manufactured dose form FSN> (clinical drug)
Example: - Product containing precisely abacavir 300 milligram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely abacavir 300 milligram and lamivudine 150 milligram and zidovudine 300 milligram/1 each conventional release oral tablet (clinical drug)
Single ingredient with BoSS <> Precise active ingredient: - Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/1 each <Manufactured dose form FSN> (clinical drug)
Example: - Product containing precisely doxazosin (as doxazosin mesylate) 4 milligram/1 each conventional release oral tablet
- Product containing precisely disopyramide (as disopyramide phosphate) 150 milligram/1 each prolonged-release oral capsule
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| Preferred Term | Preferred Term should reflect US/GB Preferred Terms consist with the component concepts (e.g. presentation strength numerator unit, precise active ingredient, manufactured dose form). Exceptions: none identified.
Single ingredient with BoSS = Precise active ingredient: - <BoSS PT> <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <manufactured dose form PT>
Exception: - The following units of measure should not be abbreviated in descriptions; they should alwasy be spelled out:
- international unit
- microgram
- million unit
- nanogram
- unit
Example: - Abacavir 300 mg oral tablet
- Abacavir 600 mg and lamivudine 300 mg oral tablet
- Abacavir 300 mg and lamivudine 150 mg and zidovudine 300 mg oral tablet
Single ingredient with BoSS <> Precise active ingredient: - <BoSS PT> (as <Precise active ingredient PT>) <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <manufactured dose form PT>
Example: - Doxazosin (as doxazosin mesylate) 4 mg oral tablet
- Disopyramide (as disopyramide phosphate) 150 mg prolonged-release oral capsule
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| Synonyms | Synonyms corresponding to the FSN are not allowed unless explicitly identified as an exception. - Exceptions: Existing instances of synonyms exactly matching the FSN will be retained until time and opportunity allows for their removal. Note that not all language reference set variations of the FSN were included as synonyms.
Additional synonyms are not allowed unless explicitly identified as an exception. - Exceptions: none identified
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Exemplars
The following illustrates the stated view:
The following illustrates the inferred view: