96. clinical utility A conclusion that the use of a medical product will lead to an overall improvement in health outcome or provide valuable information about diagnosis,
treatment, management, or prevention of a
specific disease. Clinical utility includes the potential variety of benefits or risks. This conclusion is tied to a specific drug dosing regimen, one that produces a drug blood level that gives rise to the therapeutic effect.
97. clinical validation Process to establish that an instrument, tool or test that acceptably identifies, measures or predicts the specific concept of interest. Validation of the bioanalytical method requires testing of accuracy and precision, drug stability, matrix effect and other parameters as directed by EMA and/or FDA guidances for bioanalytical method validation.
98. co-administered medicines Two or more drugs administered concurrently to a subject.
