Assessing the reproducibility of an analytical method : Data validation: 21 CFR part 11 applied
In: Journal of chromatographic science, Jg. 44 (2006), Heft 3, S. 119-122
Online
academicJournal
- print, 7 ref
Zugriff:
The reproducibility of a validated analytical method may require reassessment because of various reasons, such as the transfer between laboratories or companies, changes in the instruments or software platforms (or both), or changes in critical reagents, among others. This paper is a demonstration of an assay bridging study in evaluating reproducibility. The approach is simple but very informative and offers many advantages over existing approaches.
Titel: |
Assessing the reproducibility of an analytical method : Data validation: 21 CFR part 11 applied
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Autor/in / Beteiligte Person: | LIAO, Jason J. Z ; CAPEN, Robert C ; SCHOFIELD, Timothy L |
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Zeitschrift: | Journal of chromatographic science, Jg. 44 (2006), Heft 3, S. 119-122 |
Veröffentlichung: | Niles, IL: Preston Publications, 2006 |
Medientyp: | academicJournal |
Umfang: | print, 7 ref |
ISSN: | 0021-9665 (print) |
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