Terms & Definitions • 246 new drug application (NDA)


A process in the USA through which drug sponsors formally apply for approval by the US FDA for the sale and marketing of a new pharmaceutical.


• 247 nominal concentration


Theoretical concentration notation, used in the preparation of calibration standards and QC samples.


• 248 non-cell-based neutralizing antibody (NAb) assay


Analytical technique to assess the presence of neutralizing antidrug anti- bodies 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.


• 249 nonspecific adsorption/binding


Undesirable phenomenon of the chemical adsorption of solvated analytes to the interior surfaces of the vessels containing the solution. Typically addressed by the use of a solvent composition within which the given analyte has increased or free solubility at the appropriate concentrations, and/or the use of vessels of different material or surface chemistry.


• 250 nontargeted analysis


Analysis of the composition of a complex sample without applying predefined selection criteria, with the aim to identify previously unknown sample components. The opposite of selective (targeted) analysis in which specific data are generated.


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