Observable and Investigation Model Project

Page tree

You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 5 Next »

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.

A diagnostic product is a product with substance ingredients used in the diagnostic process, to aid the observation of phenomena which might otherwise be hard or impossible to observe. A typical example of a diagnostic product is the antibiotic product used in susceptibility testing, which is distinct from the pharmaceutical antibiotics products used for infection treatment of patients.

Example:

  • Product containing precisely amoxicillin and clavulanic acid, test disc (diagnostic product)
  • Product containing precisely amoxicillin 20 microgram and clavulanic acid 10 microgram, test disc (diagnostic product)
  • Product containing precisely amoxicillin and clavulanic acid, etest strip (diagnostic product)
  • Product containing precisely amoxicillin and clavulanic acid, 2 : 1 ratio, etest strip (diagnostic product)
  • Product containing precisely streptomycin 2.0 microgram pre milliliter (diagnostic product)

Modeling

Diagnostic products concepts shall be modeled using the proximal primitive modeling pattern ("full modeling pattern"??)

Exceptions: none identified

Stated parent concept

xxx|Diagnostic product (product)|

Possibly also 63653004 | Biomedical device (physical object) | or xxx|Diagnostic product| is also a descendant of 63653004 | Biomedical device (physical object) |. Cf. <<411115002 | Drug-device combination product (product) |

  • Exceptions: none identified
Semantic tag(diagnostic product)
Definition status

900000000000073002 | Sufficiently defined concept definition status (core metadata concept)

  • Exceptions: none identified

Attribute:

Has count of base of active ingredient

  • Range: <260299005 | Number (qualifier value) | - descendants only
  • Cardinality: 1..1

Attribute:

Has manufactured dose form

DO WE NEED TO REPRESENT THE PHYSICAL FORM, E.G. TEST DISC, STRIP, FLUID, ETC??

Attribute:

Has unit of presentation


Relationship group

 One 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, roles, and combined substances
  • Cardinality: 1..1 per relationship group
  • |Has presentation strength numerator value|

"presentation" not needed for diagnostic products.

  • 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)|
  • |Has presentation strength numerator unit|
  • Range: <258666001|Unit (qualifier value) - descendants only
  • Cardinality: 1..1 per relationship group
  • |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.

  • |Has presentation strength denominator unit|
  • Range: <732935002|Unit of presentation (unit of presentation) - descendants only
    • Exceptions: none identified
  • Cardinality: 1..1 per relationship group

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
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
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

Exemplars

The following illustrates the stated view:

The following illustrates the inferred view:

  • No labels