study design robustness testing objective
IRI: https://spec.industrialontologies.org/ontology/construct/StudyDesignRobustnessTestingObjective
Defined In: https://spec.industrialontologies.org/ontology/biopharma/DesignOfExperiments/
SubClass Of: study design objective
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › objective specification › study design objective › study design robustness testing objective
Definition
study design objective that prescribes assessing the sensitivity of one or more dependent variables to specified small variations in independent variables
Explanatory Notes
Robustness testing evaluates whether specified small variations in process or analytical-procedure parameters materially affect performance. Robustness is supported when the relevant responses continue to meet predefined performance or acceptance criteria across the studied variations.
Examples
- Testing whether small adjustments in buffer pH and flow rate (independent variables) meaningfully affect product yield (dependent variable).
Adapted From
- https://wolfson.huji.ac.il/purification/PDF/Others/GE_DOE_in_Protein_Production_and_Purification_Handbook.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 determine a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
StudyDesignRobustnessTestingObjective(x) → StudyDesignObjective(x)
Semi-Formal Natural Language Axioms
if x is a ‘study design robustness testing objective’ then x is a ‘study design objective’