A test article is a prototype, substance, or equipment used in research, development, or certification to validate performance, safety, and regulatory compliance. In medicine/FDA contexts, it refers to drugs, devices, or food additives under investigation. In engineering, it is a model used for testing.
Research A-Z
Research A-Z
+2
Key Aspects of Test Articles:
Aerospace & Engineering: These are prototypes or, pathfinders, designed to replicate specific conditions for testing.
Medical & FDA Regulations: These include investigational drugs, biological products, medical devices, and food additives, often referred to as study materials.
Regulatory Compliance: They must be controlled, often requiring specific procedures for, storage, use, and disposal.
Emergency Use: In specific, life-threatening situations, unapproved test articles may be used if no alternative exists.
UW-Madison Policy Library
UW-Madison Policy Library
+4
Contextual Definitions:
Test Article (Medicine/Food): Wikipedia
Test Article (Aerospace): Wikipedia
FDA Definition: Food and Drug Administration (.gov)
GLP Definition: readtheregs.com
Wikipedia
Wikipedia
+2
Research A-Z
Research A-Z
+2
Key Aspects of Test Articles:
Aerospace & Engineering: These are prototypes or, pathfinders, designed to replicate specific conditions for testing.
Medical & FDA Regulations: These include investigational drugs, biological products, medical devices, and food additives, often referred to as study materials.
Regulatory Compliance: They must be controlled, often requiring specific procedures for, storage, use, and disposal.
Emergency Use: In specific, life-threatening situations, unapproved test articles may be used if no alternative exists.
UW-Madison Policy Library
UW-Madison Policy Library
+4
Contextual Definitions:
Test Article (Medicine/Food): Wikipedia
Test Article (Aerospace): Wikipedia
FDA Definition: Food and Drug Administration (.gov)
GLP Definition: readtheregs.com
Wikipedia
Wikipedia
+2