Assessing the reproducibility of an analytical method.
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.
Liao
Jason J Z
JJ
Merck Research Laboratories, P.O. Box 4, WP37C-305, West Point, PA 19486, USA. jason_liao@merck.com
Capen
Robert C
RC
Schofield
Timothy L
TL
D015982:Bias; D002623:Chemistry Techniques, Analytical / Q000592:standards; D012044:Regression Analysis; D015203:Reproducibility of Results