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Kraus, V. B. Biomarkers as drug development tools: discovery, validation, qualification and use.
To reach this level, evolution of SHM development has to pass through effective process for technology maturation, development, verification, validation, qualification and finally certification.
The session intends to provide an overview about the current activities related to technology maturation, development, verification, validation, qualification and certification.
The three parts of the process involve validation, qualification, and utilisation.
Each of the various stages of validation, qualification, and utilisation would need to be revisited for that specific context, and the Hill criteria also revisited.
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Validation and qualification of biomarkers are needed to facilitate their translation into pathway-specific diagnostic tests.
Model testing approach consist of verification, calibration, sensitivity analysis, validation and qualification stages.
Hunter DJ, Losina E, Guermazi A, Burstein D, Lassere MN, Kraus V. A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials.
Validation and qualification of thermal-hydraulics system codes based on measured plant data are essential for their reliability when applied to nuclear power plant analyses.
To this purpose, the Institute for Neutron Physics and Reactor Technology INRR) at the Karlsruhe Institute of Technology (KIT) is involved in various validation and qualification activities of different CFD, subchannel and system codes.
Two different general approaches are possible: i) validation / qualification of a production / QC instrument as a whole (holistic approach), in which the computerised system is considered as a part, although significant, of the whole instrument, and validation of hardware / software is thus performed consistently; ii) validation of computerised system as an independent entity.
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