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 63.
3. lappuse
... range , recommendations on how many concentration levels should be studied with how many replicates per concentration level differ significantly [ 5-10 , 12 ] . In Conference Report II , a sufficient number of standards to define ...
... range , recommendations on how many concentration levels should be studied with how many replicates per concentration level differ significantly [ 5-10 , 12 ] . In Conference Report II , a sufficient number of standards to define ...
4. lappuse
... range, it is necessary to evaluate these parameters at least at three concentration levels (low, medium and high relative to the calibration range) [1, 2, 9, 10, 14]. In Conference Report II, it was further defined that the ...
... range, it is necessary to evaluate these parameters at least at three concentration levels (low, medium and high relative to the calibration range) [1, 2, 9, 10, 14]. In Conference Report II, it was further defined that the ...
5. lappuse
... range of LLOQ [14]. In this approach, a specific calibration curve is established from samples containing the analyte in the range of LLOQ. One must not use the calibration curve over the whole range of quantification for this de ...
... range of LLOQ [14]. In this approach, a specific calibration curve is established from samples containing the analyte in the range of LLOQ. One must not use the calibration curve over the whole range of quantification for this de ...
6. lappuse
... range of LLOQ”. However, for LOD a S/N or k-factor equal to or greater than three is usually chosen [1, 6, 9, 14]. If the calibration curve approach is used for determination of the LOD, only calibrators containing the analyte in the range ...
... range of LLOQ”. However, for LOD a S/N or k-factor equal to or greater than three is usually chosen [1, 6, 9, 14]. If the calibration curve approach is used for determination of the LOD, only calibrators containing the analyte in the range ...
8. lappuse
... ranges, it might be reasonable to also validate the analysis of QC samples containing concentrations above the highest ... range may lead to overestimation of these limits. Stability The biggest problems encountered during stability test ...
... ranges, it might be reasonable to also validate the analysis of QC samples containing concentrations above the highest ... range may lead to overestimation of these limits. Stability The biggest problems encountered during stability test ...
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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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