Use of monte carlo simulations in the assessment of calibration strategies - Part III: An evaluation of linear calibration

Bioanalysis

Volumn 5, Issue 8, 2013, Pages 959-978

  Burrows, John ^a  

^a Anastats   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ARTICLE; BIOASSAY; CALIBRATION; COMPUTER ANALYSIS; COMPUTER PROGRAM; LINEAR REGRESSION ANALYSIS; MATHEMATICAL ANALYSIS; MATHEMATICAL COMPUTING; MONTE CARLO METHOD; STATISTICAL ANALYSIS;

CALIBRATION; GUIDELINES AS TOPIC; LINEAR MODELS; MONTE CARLO METHOD; SOCIAL CONTROL, FORMAL;

EID: 84876741418     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.34     Document Type: Article

References (8)

1. US Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Rockville, MD, USA (2001).
2. Huang H, Ammerman J, Connolly P et al. Error estimates on normal least squares linear regression with replicate injection of calibration standards. Bioanalysis 4(16), 1979-1987 (2012).
3. Burrows JL. Evaluation of calibration routines in pharmaceutical and bioanalytical separations, with reference to Monte Carlo simulations. J. Pharm. Biomed. Analysis 11, 523-531 (1993).
4. Shah VP, Midha KK, Findlay JW et al. Bioanalytical method validation - a revisit with a decade of progress. Pharm. Res. 17(12), 1551-1557 (2000).
5. Analytical Methods Committee. Amc Technical Brief AMCTB No. 27. Thompson M (Ed.).
6. Royal Society of Chemistry, London, UK, 1-2 (2007).
7. Zeng QC, Zhang E, Dong H et al. Weighted least squares in calibration: estimating data variance functions in high-performance liquid chromatography. J. Chromatogr. A 1206, 147-152 (2008).
8. Deming WE. Out of the Crisis. MIT Press, MA, USA, 356-357 (1986).