308. neutralizing antibody (NAb) An antibody that is formed in vivo in response to treatment with an antigen and that binds to a drug and blocks its function. For an enzyme drug, a neutralizing antibody would block its action on the substrate. For an agonist or antagonist drug, an antibody that blocks the drug binding to its ligand would neutralize the drug. Antibodies that bind to epitopes on a drug that do not affect the function of the drug are non-neutralizing antidrug antibodies.
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309. nominal concentration Theoretical concentration notation, used in the preparation of calibration standards and QC samples.
310. non-cell-based neutralizing antibody (NAb) assay Analytical technique used to assess the presence of neutralizing antidrug antibodies in a sample without using intact cells for analysis. Typically, such an assay uses the isolated drug target coated onto a plate and generates an analytical response upon binding of the drug to its target. The presence of a neutralizing antidrug antibody will interfere with the ability of the drug to bind to its target, resulting in a measurable change in assay signal.
