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Journal of Biopharmaceutical Statistics Volume 32, 2022 - Issue 6
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Research Article

Non-inferiority testing for qualitative microbiological methods:Assessing and improving the approach in USP <1223>

Pieta C. IJzerman-Boona Center for Mathematical Sciences, MSD, Oss, The NetherlandsView further author information
,
Md Abu Manjub Department of Mathematics and Computer Science, Eindhoven University of Technology, Eindhoven, The NetherlandsView further author information
&
Edwin R. van den Heuvelb Department of Mathematics and Computer Science, Eindhoven University of Technology, Eindhoven, The NetherlandsCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-9157-7224View further author information
ORCID Icon
Pages 915-941 | Received 28 Sep 2020, Accepted 03 Apr 2022, Published online: 21 Sep 2022

References

  • Cochran, W. G. 1950. Estimation of bacterial density by means of the “most probable number”. Biometrics 6 (2):105–116. doi:10.2307/3001491.
  • De Man, J. C. 1983. MPN tables, corrected. European Journal of Applied Microbiology and Biotechnology 17 (5):301–305. doi:10.1007/BF00508025.
  • Emampour, M., P. C. IJzerman-Boon, M. A. Manju, and E. R. van den Heuvel. 2021. Optimal spiking experiment for non-inferiority of qualitative microbiological methods on accuracy with multiple microorganisms. Statistics in Biopharmaceutical Research. doi:10.1080/19466315.2021.2011397.
  • EP. 2017. 5.1.6. Alternative methods for control of microbiological quality. In European Pharmacopeia, Vol. 9.2, 4339–4348. Strasbourg: EDQM.
  • Farrington, C. P., and G. Manning. 1990. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Statistics in Medicine 9 (12):1447–1454. doi:10.1002/sim.4780091208.
  • Garthright, W. E., and R. J. Blodgett. 1996. Confidence intervals for microbiological density using serial dilutions with MPN estimates. Biometrical Journal 38 (4):489–505. doi:10.1002/bimj.4710380415.
  • Garthright, W. E., and R. J. Blodgett. 2003. FDA’s preferred MPN methods for standard, large or unusual tests, with a spreadsheet. Food Microbiology 20 (4):439–445. doi:10.1016/S0740-0020(02)00144-2.
  • IJzerman-Boon, P. C., and E. R. van den Heuvel. 2015. Validation of qualitative microbiological test methods. Pharmaceutical Statistics 14 (2):120–128. doi:10.1002/pst.1663.
  • Lachenbruch, P. A., and C. J. Lynch. 1998. Assessing screening tests: Extensions of McNemar’s test. Statistics in Medicine 17 (19):2207–2217. doi:10.1002/(SICI)1097-0258(19981015)17:19<2207::AID-SIM920>3.0.CO;2-Y.
  • Manju, M. A., E. R. van den Heuvel, and P. C. IJzerman-Boon. 2019. A comparison of spiking experiments to estimate the detection proportion of qualitative microbiological methods. Journal of Biopharmaceutical Statistics 29 (1):30–55. doi:10.1080/10543406.2018.1452027.
  • Patil, G. P., and S. Bildikar. 1966. Identifiability of countable mixtures of discrete probability distributions using methods of infinite matrices. Proceedings of the Cambridge Philosophical Society 62 (3):485–494. doi:10.1017/S030500410004010X.
  • Strijbosch, L. W. G., R. J. M. M. Does, and W. Albers. 1990. Multiple-dose design and bias-reducing methods for limiting dilution assays. Statistica Neerlandica 44 (4):241–261. doi:10.1111/j.1467-9574.1990.tb01284.x.
  • USP. 2015. <1223> Validation of alternative microbiological methods. In United States Pharmacopoeia, Vol. USP40-NF35, 1756–1770. Rockville, MD: U.S. Pharmacopoeial Convention.
  • Van den Heuvel, E. R., and P. C. IJzerman-Boon. 2013. A comparison of test statistics for the recovery of rapid growth-based enumeration tests. Pharmaceutical Statistics 12 (5):291–299. doi:10.1002/pst.1581.

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