Clinical drug

The Clinical Drug "containing precisely" (CD-precise) concept is an abstract representation of the precise active ingredient, basis of strength substance (BoSS), strength, and manufactured dose form of a drug product. It implies that the drug product must contain only the precise active ingredient(s) specified in the FSN.  

The guidance below applies to both discrete and continuous dose forms. 

Descriptions

Align FSN and PT naming and case sensitivity with the concepts selected as attribute values. 

For multiple-ingredient drug products, the BoSS must be in alphabetical order and separated by the word “and”.

The following units of measure should not be abbreviated in any descriptions; always spell out:

• microequivalent
• microliter
• microgram
• microliter (with GB spelling microlitre)
• million unit
• nanogram
• picogram
• unit

Synonyms matching the FSN are not required. 

Product strength "not equal to"

Concepts with product strength that is "not equal to" are modeled as primitive, with attributes added as described in the corresponding subpages, except that strength numerator attributes will not be added.  The appropriate Medicinal Product Form-only (MPF-only) concept will infer as a parent.

Product strength numerator values

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).

Precise active ingredient

The Precise Active Ingredient (PAI) cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a substance hydrate or solvate.

Concepts containing pancreatic enzymes are 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.