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

J Pharm Biomed Anal. 2006 Apr 11;41(1):219-27. doi: 10.1016/j.jpba.2005.11.006. Epub 2005 Dec 5.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Algorithms
  • Calibration
  • Chemistry Techniques, Analytical / methods*
  • Chemistry, Pharmaceutical / methods*
  • Chromatography, Liquid / methods*
  • Computer Simulation
  • Dose-Response Relationship, Drug
  • Models, Statistical
  • Quinolines / analysis*
  • Quinolines / chemistry
  • Regression Analysis
  • Reproducibility of Results
  • Technology, Pharmaceutical / methods*
  • Time Factors

Substances

  • Quinolines
  • piperaquine