Abstract
A modified interval hypothesis testing procedure based on paired-sample analysis is described, as well as its application in testing equivalence between two bioanalytical laboratories or two methods. This testing procedure has the advantage of reducing the risk of wrongly concluding equivalence when in fact two laboratories or two methods are not equivalent. The advantage of using paired-sample analysis is that the test is less confounded by the intersample variability than unpaired-sample analysis when incurred biological samples with a wide range of concentrations are included in the experiments. Practical aspects including experimental design, sample size calculation and power estimation are also discussed through examples.
References
Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A (2000) Pharm Res 17:1551–1557 (also see FDA/CDER (2001) Guidance for industry bioanalytical method validation (online document). FDA/CDER, Rockville, MD, see http://www.fda.gov/cder/guidance/4252fnl.pdf, last accessed 24th April 2006)
Kuselman I (2006) Accred Qual Assur 10:466–470
EURACHEM/CITAC (2003) Traceability in chemical measurement: A guide to achieving comparable results in chemical measurement (online document). EURACHEM/CITAC, Budapest, Hungary (see http://www/eurachem.il.pt, last accessed 24th April 2006)
Youden WJ, Steiner EH (1975) Statistical manual of the Association of Official Analytical Chemists. AOAC, Washington, DC
Miller JN, Miller JC (2000) (eds) Statistics and chemometrics for analytical chemistry, 4th edn. Prentice Hall, New York
Schuirmann DJ (1987) J Pharmacokinet Biop 15:657–680
Hartmann C, Smeyersverbeke J, Penninckx W, Vanderheyden Y, Vankeerberghen P, Massart DL (1995) Anal Chem 67:4491–4499
Boogaard PJ, van Sittert NJ (1995) Occup Environ Med 52:611–620
Boogaard PJ, van Sittert NJ (1996) Environ Health Perspect 104 (Suppl 6):1151–1157
Diletti E, Hauschke D, Steinijans VW (1991) Int J Clin Pharmacol Ther Toxicol 29:1–8
Phillips KF (1990) J Pharmacokinet Biop 18:137–144
Chow SC, Liu JP (eds) (1999) Design and analysis of bioavailability and bioequivalence studies, 2nd edn. Marcel Dekker, New York
Liu JP, Chow SC (1992) J Pharmacokinet Biop 20:101–104
Locke CS (1984) J Pharmacokinet Biop 12:649–655
Richter SJ, Richter C (2002) Qual Eng 14:375–380
Acknowledgement
The authors would like to thank Drs. Hans Roethig and Mohamadi Sarkar for helpful discussion and suggestions.
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Feng, S., Liang, Q., Kinser, R.D. et al. Testing equivalence between two laboratories or two methods using paired-sample analysis and interval hypothesis testing. Anal Bioanal Chem 385, 975–981 (2006). https://doi.org/10.1007/s00216-006-0417-2
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DOI: https://doi.org/10.1007/s00216-006-0417-2