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 24.
5. lappuse
... anal- yte peak. For LLOQ, S/N is usually required to be equal to or greater than 10. The estimation of baseline noise can be quite difficult for bioanalytical methods, if matrix peaks elute close to the analyte peak. LLOQ based on ...
... anal- yte peak. For LLOQ, S/N is usually required to be equal to or greater than 10. The estimation of baseline noise can be quite difficult for bioanalytical methods, if matrix peaks elute close to the analyte peak. LLOQ based on ...
6. lappuse
... anal- ysis, the stability of analyte during several freeze/thaw cycles should also be evaluated. The Conference Reports require a minimum of three cycles at two concentrations in triplicate, which has also been accepted by other au ...
... anal- ysis, the stability of analyte during several freeze/thaw cycles should also be evaluated. The Conference Reports require a minimum of three cycles at two concentrations in triplicate, which has also been accepted by other au ...
7. lappuse
... 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 very helpful during the method development/pre-valida- tion ...
... 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 very helpful during the method development/pre-valida- tion ...
9. lappuse
... Anal 12 : 1337-1343 4. Dadgar D , Burnett PE ( 1995 ) J Pharm Biomed Anal 14 : 23-31 5. Dadgar D , Burnett PE , Choc MG , Gallicano K , Hooper JW ( 1995 ) J Pharm Biomed Anal 13 : 89-97 6. Wieling J , Hendriks G , Tamminga WJ ...
... Anal 12 : 1337-1343 4. Dadgar D , Burnett PE ( 1995 ) J Pharm Biomed Anal 14 : 23-31 5. Dadgar D , Burnett PE , Choc MG , Gallicano K , Hooper JW ( 1995 ) J Pharm Biomed Anal 13 : 89-97 6. Wieling J , Hendriks G , Tamminga WJ ...
13. lappuse
Esat sasniedzis šīs grāmatas aplūkošanas reižu limitu.
Esat sasniedzis šīs grāmatas aplūkošanas reižu limitu.
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 |
Citi izdevumi - Skatīt visu
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