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Terms & Definitions • 140 functional neutralizing antibody assay


A neutralizing antibody binds to distinct functional domains of a therapeutic protein and blocks its activity or function. A functional neutralizing antibody assay detects if the antidrug antibody neutralizes the drug activity.


• 141 gas chromatography (GC)


Chromatographic technique using a carrier gas, typically helium or hydrogen, as mobile phase, where the injected liquid sample is typically immediately vaporized in the injection port. The walls of the column are coated with a thin viscous liquid layer, the stationary phase, on an inert solid support.


• 142 good clinical practice (GCP)


A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.


• 143 good laboratory practice (GLP)


A set of regulations that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.


• 144 good manufacturing practice (GMP)


A set of regulations that provides a framework within which manufacturing of drugs, food and active pharmaceutical ingredients is planned, performed, monitored, recorded, reported and archived.


• 145 gradient elution


Elution of a compound or set of compounds from an analytical column using the application of an increase in the per cent eluotropic component of the mobile phase within a single chromatographic run.


future science group www.future-science.com S37


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