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By T.J. Cleophas, Ton J. Cleophas, A.H. Zwinderman, Aeilko H. Zwinderman, T.F. Cleophas, Toine F. Cleophas, Eugene P. Cleophas

Impending the subject from an explanatory instead of mathematical stance, Cleophas and Zwinderman (both affiliated with the eu Interuniversity university of Pharmaceutical medication Lyon, France) current a textbook designed to be used in pharmaceutical schooling. They hide using statistical analyses in scientific trials, emphasizing such non-classical tools as equivalence trying out, sequential research, a number of linear regression analyses for confounding, interplay, and synergism.

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N Engl J Med Books, Waltham, MA, 1986. Swinscow TD. Statistics at square one. BMJ Publishing Group, London, UK, 1996. Glantz SA. Primer of Biostatistics. McGraw-Hill, Singapore, 1992. Motulsky H. Intuitive Statistics. Oxford University Press. New York, 1995. Kuhlmann J, Mrozikiewicz A. What should a clinical pharmacologist know to start a clinical trial? Zuckschwerdt Verlag, Munich, 1998. De Vocht A. SPSS basic guide book. Bijleveld Press, Amsterdam, 1998. Hays WL. Statistics. Holt, Rine and Winston, Toronto, Ontario, 1988.

55 ξ ... 45 (b ... 45 (c .. 847 (d .. 363 (e .. 45 (f .. 001 according to the chi-square table (see APPENDIX). THE ANALYSIS OF SAFETY DATA OF DRUG TRIALS 51 4. , different diagnostic tests are performed in one subject. , 315 subjects are tested for hypertension using both an automated device (test −1) and a sphygmomanometer (test − 2), (Table 2). Table 2. 5 54 + 14 ________________________________________ Chi - square McNemar = 184 subjects scored positive with both tests and 63 scored negative with both tests.

Table 2. 5 54 + 14 ________________________________________ Chi - square McNemar = 184 subjects scored positive with both tests and 63 scored negative with both tests. These 247 subjects therefore give us no information about which of the tests is more likely to score positive. The information we require is entirely contained in the 68 subjects for which tests did not agree (the discordant pairs). Table 2 shows how the chi-square value is calculated. 001. , McNemar’s test can not be applied. For that purpose Cochran’s test or logistic regression analysis is adequate (chapter 14).

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