Definitions


402. regulated bioanalysis Bioanalysis conducted in compliance with regulatory requirements (e.g., US FDA, EMA, ANVISA or MHLW).


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403. regulatory validation The conduct and reporting of experimental testing of a method to demonstrate that the concentration data are scientifically accurate and reproducible to allow valid decision-making for the intended purpose of the study, and comply with regulated bioanalytical standards as defined in guidance and guidelines.


404. reintegration Reanalysis of the chromatographic peak.


405. relative bioavailability The bioavailability of a formulation of a drug compared with that of an alternative formulation.


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