Calibration and validation

Because physicochemical cause-and-effect models are the basis of all measurements, statistics are used to optimize, validate, and calibrate the analytical method, and then interpolate the obtained measurements the models tend to be very simple (i.e., linear) in the concentration interval used. 

Brommage, R. (2003) Validation and calibration of DEXA body composition in mice. Am J Physiol Endocrinol Metab 285, E454-459. 

De BiLvre I Kaarls R, Rasberry S, Reed W (1995) Metrology and the role of reference materials in validation and calibration for traceability of chemical measurements. Proceedings of the 1995 NCSL Workshop and Symposium, pp 479 494... 

Present-day analytical laboratories are increasingly under pressure to supply objective evidence of their technical competence, of the reliability of their results and performance, and to seek formal certification or accreditation. This pressure may come from the laboratory s customers (e.g., industry and national bodies) but may also be due to scientific considerations. A QM system in place, validation of methods, uncertainty evaluation, the use of primary standards and CRMs, participation in ILCs, and PT, all serve to assure and demonstrate the quality of measurements. Compared to, say, 30 years ago, the stability of the equipment now available is much improved, and a greater range of RMs for method validation and calibration is accessible. Nevertheless, to achieve mutual (international) acceptance of various bodies of evidence for QA activities, a number of protocols have been developed. The most widely recognized protocols used in chemical measurements and testing are the ISO Guide 9000 2000, ISO/IEC 17025 2005, and OECD Guidelines for GLP, as well as its national and sector equivalents. 

FIGURE 7.9 The integrative research approach to assess and predict stress and disturbance at the ecosystem and landscape level and to validate and calibrate the extrapolation tools developed. Source Redrawn after Brock (1998). 

Spreadsheets are often used to maintain recipes or analytical methods that directly include calculations. This may be very helpful to overcome the disabilities of LIMS systems or the poor functionality of an ERR Analytical method validation, calculations of cleaning validation, and calibration lists are other areas where spreadsheets may be used within the pharmaceutical industry. This category of spreadsheet typically takes the form of preconfigured templates. Before spreadsheets were so widely used, programmable pocket calculators were used to perform such functions. 

Because radiolabeling techniques are not precise and specific activities of the isotopes can vary, validation and calibration should be done for each radiolabeled aerosol produced. In particular, the measurement of emitted doses... 

The 5x5 point sources array data is a good set for validation and calibration of the WHT system. However, one of the objectives of WHT is to observe astronomically representative test scenes, which can be binary sources. 

The lEUBK model has been more exhaustively validated and calibrated than any like model being used today as a site-specific risk assessment tool by EPA or others. This evaluation ranged from verifying the basic computational soundness of the model to the range of its applications, independently evaluated by EPA s Science Advisory Board, Clean Air Scientific Advisory Committee (SAB/CASAC). SAB approved its use in stationary source air Pb exposure assessment and at hazardous waste sites containing lead (SAB/ CASAC, 1989, 1992). 

Validation and calibration comparisons of the O Flaherty model with measured exposure data have been reported, but fewer than were done for the lEUBK system. While the validation and calibration exercises carried out by O Flaherty have included test animal dosing data and experimental PbB comparisons for rats (O Flaherty, 1991) and nonhuman primates (Cynomolgus monkeys, Franklin et al., 1997), such efforts also included children and adults (O Flaherty, 1993, 1995, 1998). 

The review and discussion of existing methods sets out the rationale for a combined method, called FaMlVE (Failure Mechanism Identification and Vulnerability Evaluation), and developed by the first author and her co-researchers, in the past decade. The hypotheses and analytical approach to derive capacity curves and fragility functions are presented in detail in section Development of Analytical Methods FaMIVE. Results obtained from the FaMIVE method are presented in section Damage Thresholds and Performance Indicators in terms of damage limit states and drift and compared with the recommendation of Eurocode 8 (ECS) (CEN 2005) and experimental evidence to discuss issues of validation and calibration. 

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