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 21.
. lappuse
... drug residues and element contaminants in the EC ............................ 159 Methods validation: AOAC's three validation systems 163 Observing validation, uncertainty determination and traceability in developing Nordtest test ...
... drug residues and element contaminants in the EC ............................ 159 Methods validation: AOAC's three validation systems 163 Observing validation, uncertainty determination and traceability in developing Nordtest test ...
2. lappuse
... Drug Admin- istration (FDA) for their own use [11]. Besides, it should be mentioned that some journals like the Journal of Chromatography B [12] or Clinical Chemistry have es- tablished their own criteria for validation. Two other ...
... Drug Admin- istration (FDA) for their own use [11]. Besides, it should be mentioned that some journals like the Journal of Chromatography B [12] or Clinical Chemistry have es- tablished their own criteria for validation. Two other ...
3. lappuse
... drugs of abuse in blood ) should of course be able to differentiate all interesting analytes from each other and from the matrix . The LLOQ is the lowest amount of an analyte in. hyphenated mass spectrometric methods are used for de ...
... drugs of abuse in blood ) should of course be able to differentiate all interesting analytes from each other and from the matrix . The LLOQ is the lowest amount of an analyte in. hyphenated mass spectrometric methods are used for de ...
7. lappuse
... drugs are usually ingested under controlled conditions. Therefore, there is no need to prove the ingestion of this drug. Due to this fact the selectivity evaluation can be based on the acceptability of precision and accuracy data at the ...
... drugs are usually ingested under controlled conditions. Therefore, there is no need to prove the ingestion of this drug. Due to this fact the selectivity evaluation can be based on the acceptability of precision and accuracy data at the ...
9. lappuse
... Drug Administra- tion ( 2001 ) Guidance for industry , bio- analytical method validation http://www.fda.gov/cder/guidance/in- dex.htm 12. Lindner W , Wainer IW ( 1998 ) J Chro- matogr B 707 : 1-2 13. International Conference on Harmoni ...
... Drug Administra- tion ( 2001 ) Guidance for industry , bio- analytical method validation http://www.fda.gov/cder/guidance/in- dex.htm 12. Lindner W , Wainer IW ( 1998 ) J Chro- matogr B 707 : 1-2 13. International Conference on Harmoni ...
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