414. 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.
415. robustness A measure of an analytical procedure’s capacity to remain unaffected by small but deliberate variations in method parameters. Provides an indication of its reliability during normal usage.
416. ruggedness A measure of reproducibility of test results under normal, expected operational conditions from irregular, extraneous influences on operational parameters.
417. r-squared A term, often referred to as the determination coefficient, used to assess the fitness of a relationship when performing regression.
