target range value expression
IRI: https://spec.industrialontologies.org/ontology/construct/TargetRangeValueExpression
Defined In: https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/
SubClass Of: range value expression
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › range value expression › target range value expression
Definition
range value expression that prescribes a preferred interval for a quality attribute, material attribute, performance indicator, or process parameter at a particular time point or during a particular time interval of some planned process
Explanatory Notes
Target range is used to describe the preferred band for an attribute, indicator, or parameter and does not, by itself, state what variation is permissible. When a parameter range is intended to state permissibility or demonstrated acceptability, terms such as normal operating range (NOR) and proven acceptable range (PAR) should be used instead.
Examples
- target pH range of 7.0–7.4 for a prepared buffer before use; target osmolality range of 280–320 mOsm/kg for a prepared media lot at release; target viability range of 90–95 % for a cell culture before inoculation; target galactosylation range of 45–55 % for a product quality attribute at harvest
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnologicalbiological-entities_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
TargetRangeValueExpression(x) → RangeValueExpression(x)
Semi-Formal Natural Language Axioms
if x is a ‘target range value expression’ then x is a ‘range value expression’