Stat 505 - Environmental Statistics - References for part 4
Regulatory connections
Equivalence tests: Books / Book Chapters
Chow, S-C and Liu, J-P. 2000. Design and Analysis of Bioavailability and Bioequivalence Studies,
2nd ed. Marcel-Dekker.
U.S. Food and Drug Administration. 2001. Guidance for Industry: Statistical Approaches
to Establishing Bioequivalence. Center for Drug Evaluation and Research. Available at
http://www.fda.gov/Cder/guidance/3616fnl.pdf
Wellek, S. 2002. Testing Statistical Hypotheses of Equivalence. Chapman and Hall/CRC.
Compilation of many different approaches and applications. Both theory and application.
Equivalence tests: General Papers
Anderson, S. and Hauck, W.W. 1990. Consideration of individual bioequivalence. J. Pharmocokin. Biopharm. 18:259-273.
Bross, I.D. 1985. Why proof of safety is much more difficult than proof of hazard. Biometrics
41:785-793.
Argues that proof of safety requires much larger sample sizes.
Millard, S.P. 1987. Proof of safety vs proof of hazard. Biometrics 43:719-725.
One reaction to Bross, casting the problem in terms of power.
Schuirmann, D.J. 1987. A comparions of the two one-sided tests procedure and the power
approach for assessing equivalence of average bioavailability. J. Pharmocokin. Biopharm.
15:657-680.
The standard reference for the two one-sided tests procedure.
Equivalence tests: Environmental applications
Cole, R. and McBride, G. 2004. Assessing impacts of dredge spoil disposal using equivalence
tests: implications of a precautionary (proof of safety) approach. Marine Ecology Progress
Series 279:63-72.
Erickson, W.P. and McDonald, L. L. 1995. Tests of bioequivalence of control media and test
media in studies of toxicity. Env. Tox. and Chem. 14:1247-1256.
McBride, G.B. 1997. Potential for use of equivalence testing in environmental science and
management. NIWA, Hamilton NZ.
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McBride, G.B. 2002. Statistical methods helping and hindering environmental science and
management. J. Agric. Biol. Env. Stats. 7:300-305.
Parkhurst, D.F. 2001. Statistical significance tests: equivalence and reverse tests should reduce
misinterpretation. Bioscience 51:1051 - 1057.
Equivalence tests: More powerful tests than TOST
Berger, R.L. and Hsu, J.L. 1996. Bioequivalence trials, intersection-union tests and equivalence
confidence sets. Statistical Science 11:293-319 (with discussion).
The discussions are as interesting as the main paper. Meredith or Hauck/Anderson’s for
how statistics and practice interact.
Brown, L.D., Hwang, G.T.J. and Munk, A. 1997. An unbiased test for the bioequivalence
problem. Ann. Stat. 25:2345-2367.
Standards: books
Barnett, V. and O’Hagan, A. 1997. Setting Environmental Standards: the statistical approach
to handling uncertainty and variability. Chapman and Hall.
A report to the Royal Commission on Environmental Pollution. More policy as technical
details, in spite of the authors (both statisticians) and title. Official Gov’t response also in
Parks Library, ’Government Response to the Royal Commission on Environmental Pollution’s Twenty-First Report, Setting Environmental Standards’.
Gibbons, R.D. 1994. Statistical Methods for Groundwater Monitoring. Wiley
Basic problem is ’is the groundwater at this well site contaminated?’ Details on r out of m
prediction calculations, applied to sampling and decision rules for groundwater.
Hahn, G.U. and Meeker, W.Q. 1991. Statistical Intervals. A guide for practitioners. Wiley
Introduction to confidence, prediction, and tolerance intervals. Includes extensive tables.
Gilbert, R. Statistical Methods for Environmental Pollution Monitoring, also has a chapter on
tolerance intervals.
Odeh, R.E. and Owen, D.B. 1980. Tables for Normal Tolerance Limits, Sampling Plans, and
Screening. Marcel Dekker
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Tolerance intervals: environmental applications
Breidt, F.J., Boes, D.C, Wagner, J.I, and Flora, M.D. 1991. Antidegredation water quality
criteria for the Delaware River: a distribution-free statistical approach. Water Resources
Bulletin 27:593-602.
Smith, J.G., Beauchamp, J.J, and Stewart, A.J. 2005. Alternative approach for establishing
acceptable thresholds of macroinverebrate community metrics. J. North American Benthological Society 24:428-440.
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