444. stage-appropriate scientific validation One process of scientific validation where, depending on the stage of development in which the study is supported, the proposed assay criteria for scientific validation may be different. In all stages, however, the reported concentrations support valid and documented decisions in the study. When a compound progresses in development, the study could change from nonpivotal (internal decision) to pivotal. Regulatory validation can be considered as the ultimate level of stage-appropriate scientific validation.
445. standard curve The relationship between the experimental response values and the analytical concentrations of the calibrants (also called ‘calibration curve’). The term may also refer to the physical samples used to generate the experimental responses and with quality controls to determine the validity.
446. standard operating procedure (SOP) Document that describes the recurring operations relevant to the quality of an activity that enables proper, consistent execution of the operations by someone knowledgeable in the field.
