Assessing the Agreement between Two-Quantitative Assays with Repeated Measurements

Journal of Biopharmaceutical Statistics

Volumn 14, Issue 1, 2004, Pages 201-212

  Shao, Jun ^a   Zhong, Bob ^b  

^a University of Wisconsin Madison   (United States)

^b NeoPharm Inc   (United States)

Author keywords

Agreement; Assay validation; Measurement error; Method comparison; Nonconstant error variances; Repeated measurements

Indexed keywords

ARTICLE; BIOEQUIVALENCE; LINEAR REGRESSION ANALYSIS; MEASUREMENT; PRIORITY JOURNAL; QUANTITATIVE ASSAY; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICS; VALIDATION PROCESS;

DATA INTERPRETATION, STATISTICAL; HUMANS; MODELS, STATISTICAL; THERAPEUTIC EQUIVALENCY;

EID: 1542378975     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120028515     Document Type: Article

References (16)

1. Abbott Laboratories (1998). ARCHITECT™ SYSTEM Ferritin package insert.
2. Chinchilli, V. M., Martel, J. K., Kumanyika, S., Lloyd, T. (1996). A weighted concordance correlation coefficient for repeated measurement design. Biometrics 52:341-353.
3. Deming, W. E. (1943). Statistical Adjustment of Data. New York: Wiley.
4. FDA (2001). Guidance for Industry on Statistical Approaches to Establishing Bioequivalence. Rockville, Maryland: Center for Drug Evaluation and Research, Food and Drug Administration.
5. King, S. T., Chinchilli, V. M. (2001). A generalized concordance correlation coefficient for continuous and categorical data. Stat. Med. 20:2131-2147.
6. Laurent, R. T. (1998). Evaluating agreement with a gold standard in method comparison studies. Biometrics 54:537-545.
7. Lin, L. I. (1989). A concordance correlation coefficient to evaluate reproducibility. Biometrics 45:255-268.
8. Lin, L. I. (1992). Assay validation using concordance correlation coefficient. Biometrics 48:599-604.
9. Lin, L. I. (2000). Total deviation index for measuring individual agreement with applications in laboratory performance and bioequivalence. Stat. Med. 19:255-270.
10. Lin, L. I., Hedayat, A. S., Sinha, S., Yang, Min (2002). Statistical methods in assessing agreement: Models, issues, and tools. J. Am. Stat. Assoc. 97:257-270.
11. Linnet, K. (1990). Estimation of the linear relationship between the measurements of two methods with proportional errors. Stat. Med. 9:1463-1473.
12. Passing, H., Bablok, W. (1983). A new biometrical procedure for testing the equality of measurements from two different analytical methods. J. Clin. Chem. Clin. Biochem. 21:709-720.
13. Passing, H., Bablok, W. (1984). Comparison of several regression procedures for method comparison studies and determination of sample sizes. J. Clin. Chem. Clin. Biochem. 22:431-455.
14. Shao, J. (2003). Mathematical Statistics. 2nd ed. New York: Springer.
15. Zhong, B., Shao, J. (2002). Testing the agreement of two quantitative assays. Comm. Statist. A 31(8):1283-1299.
16. Zhong, B., Shao, J. (2003). Evaluating the agreement of two quantitative assays with repeated measurements. J. Biopharm. Stat. 13:75-86.