Validation in Chemical MeasurementPaul De Bièvre, Helmut Günzler Springer Science & Business Media, 2005. gada 6. dec. - 168 lappuses The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance." They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results. |
No grāmatas satura
1.–5. rezultāts no 34.
2. lappuse
... meth- odology and practical issues [14]. Both can be down- loaded from the ICH homepage free of charge (www.ich.org). Finally, in 2001 Vander Heyden et al. published a paper on experimental designs and evalua- tion of robustness ...
... meth- odology and practical issues [14]. Both can be down- loaded from the ICH homepage free of charge (www.ich.org). Finally, in 2001 Vander Heyden et al. published a paper on experimental designs and evalua- tion of robustness ...
4. lappuse
... meth- od (β-error) is quite high. Causon proposed the same ac- ceptance limits of 15% RSD for precision and ±15% for accuracy (bias) for all concentration levels [8]. The guidelines established by the Journal of Chroma- tography B ...
... meth- od (β-error) is quite high. Causon proposed the same ac- ceptance limits of 15% RSD for precision and ±15% for accuracy (bias) for all concentration levels [8]. The guidelines established by the Journal of Chroma- tography B ...
6. lappuse
... meth- ods. Long-term stability Upper limit of quantification (ULOQ) The upper limit of quantification is the maximum analyte concentration of a sample that can be quantified with ac- ceptable precision and accuracy (bias). In general ...
... meth- ods. Long-term stability Upper limit of quantification (ULOQ) The upper limit of quantification is the maximum analyte concentration of a sample that can be quantified with ac- ceptable precision and accuracy (bias). In general ...
7. lappuse
... meth- od to small changes that might occur during routine anal- ysis like small changes of pH values, mobile phase com- position, temperature, etc. Full validation must not nec- essarily include ruggedness testing; it can however be ...
... meth- od to small changes that might occur during routine anal- ysis like small changes of pH values, mobile phase com- position, temperature, etc. Full validation must not nec- essarily include ruggedness testing; it can however be ...
14. lappuse
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Saturs
1 | |
10 | |
Clinical reference materials for the validation of | 31 |
Qualification and validation of software and computer | 42 |
Validation of the uncertainty evaluation for | 63 |
Validation criteria for developing ionselective | 73 |
quality assurance | 148 |
Is the estimation of measurement uncertainty a viable | 155 |
Different approaches to legal requirements | 159 |
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Bieži izmantoti vārdi un frāzes
acceptance Accred Qual Assur accuracy Anal analysis analyte concentration analytical chemistry analytical measurement analytical method analytical procedure Anklam AOAC AOAC INTERNATIONAL application assessment bias calculated calibration curve capillary cation certified certified reference materials Chem chemical clinical components computer systems corrosion criteria CRMs defined detector determination documentation drug EURACHEM evaluation experimental factors functions Hewlett-Packard HPLC injection installation instrument interlaboratory International laboratory linearity LLOQ matrix measurement uncertainty ment meth method validation Metrology mmol/l obtained operating parameters peak performance pharmaceutical phase precision protocol qualification quality assurance quantitative quinizarin range recovery reference materials relative standard deviation reliability reproducibility requirements ruggedness testing sample scope of accreditation solution solvent red 24 solvent yellow 124 specifications Springer-Verlag standard deviation Table tainty test methods tion trueness type of tests uncer uncertainty associated uncertainty estimation vali vendor verification Waldbronn