biological activity
IRI: https://spec.industrialontologies.org/ontology/construct/BiologicalActivity
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/
SubClass Of: capability
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:disposition › capability › biological activity
Definition
capability of a drug substance, drug product, or relevant process intermediate material to achieve a defined biological effect
Explanatory Notes
Biological activity is modeled as the capability of a drug substance, drug product, or relevant process intermediate material to produce the biological effect for which it is being evaluated. It should be distinguished from drug potency: biological activity is the capability, while drug potency is the quality that characterizes the degree to which that biological activity is exhibited
Examples
- the target-binding biological activity of a monoclonal antibody drug product; the neutralizing biological activity of an antibody drug substance; the enzymatic biological activity of an enzyme therapeutic;
Adapted From
- https://database.ich.org/sites/default/files/Q6B%20Guideline.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 a set of necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
BiologicalActivity(x) → Capability(x) ∧ ∃m ((MaterialProduct(m) ∨ ProcessIntermediateMaterial(m)) ∧ capabilityOf(x, m))
Semi-Formal Natural Language Axioms
if x is a ‘biological activity’ then x is a ‘capability’ that is the ‘capability of’ some ‘material product’ or some ‘process intermediate material’