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 62.
. lappuse
... definition . Webster's Dictionary of the English language ( 1992 ) tells us that val- idation is ' making or being made valid ' . Obviously valida ... defined in the VIM . Alison Gillespie Laboratory of the Government Chemist , Queens Road.
... definition . Webster's Dictionary of the English language ( 1992 ) tells us that val- idation is ' making or being made valid ' . Obviously valida ... defined in the VIM . Alison Gillespie Laboratory of the Government Chemist , Queens Road.
2. lappuse
... definition was recommended (cf. Accuracy). However, the ICH terminology lacked a definition for stability, which is an ... defined as fol- lows: “Selectivity is the ability of the bioanalytical meth- od to measure unequivocally and to ...
... definition was recommended (cf. Accuracy). However, the ICH terminology lacked a definition for stability, which is an ... defined as fol- lows: “Selectivity is the ability of the bioanalytical meth- od to measure unequivocally and to ...
3. lappuse
... define adequately the relationship between concentration and response was demanded . Furthermore , it was stated that at least five to eight concentration levels should be studied for linear and maybe more for non - linear rela ...
... define adequately the relationship between concentration and response was demanded . Furthermore , it was stated that at least five to eight concentration levels should be studied for linear and maybe more for non - linear rela ...
4. lappuse
... defined and obviously often used interchangeably with each other and also with the term intermediate precision. Reproducibility. Reproducibility expresses the precision between laboratories (collaborative studies, usually ap- plied to ...
... defined and obviously often used interchangeably with each other and also with the term intermediate precision. Reproducibility. Reproducibility expresses the precision between laboratories (collaborative studies, usually ap- plied to ...
5. lappuse
... defines the LLOQ as the lowest concentra- tion of a sample that can still be quantified with accept- able precision and ... defined as the height of the analyte peak (signal) and the amplitude between the highest and lowest point of the ...
... defines the LLOQ as the lowest concentra- tion of a sample that can still be quantified with accept- able precision and ... defined as the height of the analyte peak (signal) and the amplitude between the highest and lowest point of the ...
Saturs
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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