Terms & Definitions • 363 response function


A mathematical treatment that adequately describes the relationship between instrument response (e.g., peak area or height ratio) and the concentration (amount) of analyte in the sample. Response function is defined within a given range.


• 364 retention time (RT)


The time taken for an analyte to reach the detector after injection and migration through a chromatographic column.


• 365 reversed-phase chromatography


Type of chromatography employing a nonpolar stationary phase and a polar mobile phase. Hydrophilic analytes have limited affinity for the stationary phase and are eluted first, while hydrophobic analytes tend to adsorb to the stationary phase and are eluted by decreasing the polarity of the mobile phase.


• 366 risk-based approach


Has multiple meanings in drug development, all relating to the evaluation of the risk of failure versus the resource investment required to maintain the required quality level. The regulatory guidance and white papers by health authority authors support a risk-based approach for companies designing their own tiered testing schemes (i.e., fit-for-purpose bioanalytical strategy). This is also used in terms of a tiered approach for metabolite analyses and in consideration of biomarker analyses.


• 367 robustness


The capability of a method to maintain adequate performance under normal variations of the intrinsic operational parameters associated with it.


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