Search


Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

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)

Semantic tag(clinical drug)
Definition status

900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)|

Exceptions:

    • Concepts with product strength that is "not equal to" (e.g. with product strength expressed as a range, greater than, or less than) will have definition status 900000000000074008 |Necessary but not sufficient concept definition status (core metadata concept)

Attribute:

Has manufactured dose form

Range: 736542009 |Pharmaceutical dose form (dose form)

      • NOTE: While the allowed range for this attribute is broader, the CD-precise continuous dose from 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)|)

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 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) - descendants only, excluding concepts representing structural groupers, dispositions, or combined substances

Cardinality: 1..1 per relationship group

Notes:

  • The 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) - descendants only, 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

Expression of product strength in metric units is preferred.

To avoid semantically equivalent concepts, product strength for metric units are normalized as follows:

  • Use milligram if value is <1000; if > then convert to gram
  • Use microgram if value is <1000; if > then convert to milligram
  • Use nanogram if value is <1000; if > then convert to microgram
  • Use picogram if value is <1000; if > then convert to nanogram

To avoid semantically equivalent concepts, product strength for units are normalized as follows:

  • 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)|

Repeating decimals are rounded to three decimal places (with 5 and above rounded up and 4 and below rounded down).

  • Has concentration strength numerator unit

Range: 767524001 |Unit of measure (qualifier value)| - descendants only

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 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.

  • Has concentration strength denominator unit

Range: 767524001 |Unit of measure (qualifier value)| - descendants only

Cardinality: 1..1 per relationship group


  • For Clinical drug concepts with liquid dose form, the denominator unit should be 258773002 |Milliliter (qualifier value)|.
  • For Clinical drug concepts with 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.

...