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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)

Concentration strength units

For solids and semi-solids, a concentration strength will be mass/mass (weight/weight) – usually mg/g.*

  • Solid = pill, tablet, suppository, tape, patch, lozenge, implant, gum, capsule, etc.
  • Semi-solid = cement, cream, gel, ointment, paste, poultice

For liquids, a concentration strength will be mass/volume (weight/volume) – usually mg/mL.*

  • Liquid = solution, suspension, tincture, spirit, emulsion, foam, lotion, oil, lacquer, etc.

*Requests for new concepts that conflict with the above require a clear justification for the variance.

Modeling

Stated parent

763158003 |Medicinal product (product)|

Semantic tag(clinical drug)
Definition status

Defined

Exception:

    • 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

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)|)

Attribute:

Count of base of active ingredient (attribute)

Concrete Type: Integer

Range: >#0..

Cardinality: 1..1

Relationship groupOne relationship group containing one instance of each of the following attributes is required for each precise active ingredient.
  • 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.
  • Has basis of strength substance

Range:  <105590001 |Substance (substance) excluding concepts representing structural groupers, dispositions, or combined substances

Cardinality:  1..1 per relationship group

  • Has concentration strength numerator value

Concrete Type:  Decimal

Range:  >#0..

Cardinality:  1..1 per relationship group

  • Has concentration strength numerator unit

Range: <767524001 |Unit of measure (qualifier value)|

Cardinality: 1..1 per relationship group

  • 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.

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.

  • 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
    Concept
    t258682000 |gram (qualifier value)|
    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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