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A new approach to evaluate regression models during validation of bioanalytical assays

Journal article
Authors T Singtoroj
Joel Tärning
A Annerberg
Michael Ashton
Y Bergqvist
NJ White
N Lindegårdh
NP Day
Published in J Pharm Biomed Anal
Volume 41
Issue 1
Pages 219-27
Publication year 2006
Published at Institute of Neuroscience and Physiology, Department of Pharmacology
Pages 219-27
Language en
Keywords bioanalys
Subject categories Pharmacy

Abstract

The quality of bioanalytical data is highly dependent on using an appropriate regression model for calibration curves. Non-weighted linear regression has traditionally been used but is not necessarily the optimal model. Bioanalytical assays generally benefit from using either data transformation and/or weighting since variance normally increases with concentration. A data set with calibrators ranging from 9 to 10000 ng/mL was used to compare a new approach with the traditional approach for selecting an optimal regression model. The new approach used a combination of relative residuals at each calibration level together with precision and accuracy of independent quality control samples over 4 days to select and justify the best regression model. The results showed that log-log transformation without weighting was the simplest model to fit the calibration data and ensure good predictability for this data set.

Page Manager: Webmaster|Last update: 9/11/2012
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