pharmaceutical product related impurity role
IRI: https://spec.industrialontologies.org/ontology/construct/PharmaceuticalProductRelatedImpurityRole
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: material impurity role
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › material impurity role › pharmaceutical product related impurity role
Direct subclasses:
Definition
material impurity role held by a material entity that is related to the targeted drug substance or drug product but is not part of the desired product composition or accepted product heterogeneity at the relevant stage and does not have properties comparable to the desired product with respect to safety, efficacy or activity
Examples
- the pharmaceutical product related impurity role of high-molecular-weight monoclonal antibody aggregates in a drug substance intermediate when those aggregates increase safety risk through potential immunogenicity; the pharmaceutical product related impurity role of clipped antibody fragments in a process intermediate when the fragments reduce antigen-binding activity or Fc-mediated function; the pharmaceutical product related impurity role of oxidized monoclonal antibody species in a drug product when oxidation reduces biological activity or product stability;
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 necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
PharmaceuticalProductRelatedImpurityRole(x) → MaterialImpurityRole(x) ∧ ∃m (MaterialEntity(m) ∧ roleOf(x, m) ∧ ∃w ((MaterialProduct(w) ∨ ProcessIntermediateMaterial(w)) ∧ properContinuantPartOfAtAllTimes(m, w)))
Semi-Formal Natural Language Axioms
if x is a ‘pharmaceutical product related impurity role’ then x is a ‘material impurity role’ that is the ‘role of’ some ‘material entity’ that is a ‘proper continuant part of at all times’ some ‘material product’ or some ‘process intermediate material’
Description Logic
constr:PharmaceuticalProductRelatedImpurityRole ⊑ constr:MaterialImpurityRole
constr:PharmaceuticalProductRelatedImpurityRole ⊑ ∃ constr:roleOf .(bfo:material_entity ⊓ ∃ bfo:proper_continuant_part_of_at_all_times .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial))
SubClassOf: constr:MaterialImpurityRole
SubClassOf: constr:roleOf some (bfo:material_entity and bfo:proper_continuant_part_of_at_all_times some (constr:MaterialProduct or constr:ProcessIntermediateMaterial))