drug potency
IRI: https://spec.industrialontologies.org/ontology/construct/DrugPotency
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/
SubClass Of: bfo:quality
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:quality › drug potency
Definition
quality of a drug substance, drug product, or relevant process intermediate material that is the quantitative degree of its biological activity
Explanatory Notes
According to ICH Q6B, a relevant validated potency assay should ordinarily be part of the specification for a biotechnological or biological drug substance or drug product. In justified cases, physicochemical methods may be used for quantitative assessment when sufficient physicochemical information is available, an appropriate correlation with biological activity has been demonstrated, and the manufacturing history or corresponding cross-stage assay strategy supports their use. Potency should be distinguished from a simple determination of product quantity because it characterizes the degree of the relevant biological activity.
Examples
- the drug potency of a monoclonal antibody drug product determined by a cell-based neutralization assay; the drug potency of an enzyme therapeutic drug substance determined by an enzymatic activity assay; the drug potency of a cytokine drug product determined by a receptor-mediated bioassay; the drug potency of a vaccine antigen lot determined by an immunological potency assay
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-production-characterisation-and-specification-monoclonal-antibodies-and-related-products-revision-1_en.pdf and https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-6-b-test-procedures-and-acceptance-criteria-biotechnologicalbiological-products-step-5_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 for creating a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
DrugPotency(x) → Quality(x) ∧ ∃m∃a((MaterialProduct(m) ∨ ProcessIntermediateMaterial(m)) ∧ qualityOf(x,m) ∧ BiologicalActivity(a) ∧ capabilityOf(a,m) ∧ specificallyDependsOn(x,a))
Semi-Formal Natural Language Axioms
if x is a ‘drug potency’ then x is a ‘quality’ that is the ‘quality of’ some ‘material product’ or ‘process intermediate material’ m and ‘specifically depends on’ some ‘biological activity’ that is the ‘capability of’ that same m
Description Logic
constr:DrugPotency ⊑ bfo:quality
constr:DrugPotency ⊑ ∃ bfo:specifically_depends_on .constr:BiologicalActivity
constr:DrugPotency ⊑ ∃ constr:qualityOf .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial)
SubClassOf: bfo:quality
SubClassOf: bfo:specifically_depends_on some constr:BiologicalActivity
SubClassOf: constr:qualityOf some (constr:MaterialProduct or constr:ProcessIntermediateMaterial)