By Stefan Wellek
Equivalence trying out has grown considerably in value during the last 20 years, particularly as its relevance to numerous purposes has turn into understood. but released paintings at the common method is still scattered in experts' journals, and for the main half, it makes a speciality of the fairly slender subject of bioequivalence assessment.
With a miles broader viewpoint, trying out Statistical Hypotheses of Equivalence offers the 1st accomplished therapy of statistical equivalence checking out. the writer addresses a spectrum of particular, two-sided equivalence checking out difficulties, from the one-sample challenge with as a rule dispensed observations of mounted identified variance to difficulties related to numerous samples and multivariate facts. The therapy encompasses a concise assessment of easy mathematical effects on optimum checks for equivalence, and the writer makes to be had on the net a set of laptop courses that let effortless implementation of the equipment presented.
In a box as advanced and wealthy in strength functions as equivalence trying out, checking out Statistical Hypotheses of Equivalence stands by myself as a coherent reference that furnishes either the theoretical and sensible instruments wanted for facing equivalence trials of any complexity and in any section.
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Extra info for Testing statistical hypotheses of equivalence and noninferiority
Example text
Wellek, S. (1996) A new approach to equivalence assessment in standard comparative bioavailability trials by means of the Mann-Whitney statistic. Biometrical Journal 38: 695–710. 400 REFERENCES Wellek, S. (2000a) Bayesian construction of an improved parametric test for probability-based individual bioequivalence. Biometrical Journal 42: 1039–52. Wellek, S. (2000b) On a reasonable disaggregate criterion on population bioequivalence admitting of resampling-free testing procedures. Statistics in Medicine 19: 2755–67.
For the placebo phase, the experimental and measurement procedure was exactly the same as for verum except for replacing olestra with conventional triglycerides at each meal. 1 gives the individual results for norgestrel and the maximum concentration Cmax as the pharmacokinetic parameter of interest. According to the general objective of the trial, let us aim at establishing that the consumption of olestra does not reduce the bioavailability of norgestrel (as measured by Cmax ) to a relevant extent.
60, versus the two-sided alternative p = p◦ . 41, the researchers came to the conclusion that the therapeutic equivalence of the generic to the reference formulation could be taken for granted, implying that the basic requirement for switching to the new formulation whenever confining the costs of treatment is an issue, was satisfied. Unfortunately, it follows from the logical asymmetry between null and alternative hypothesis mentioned at the beginning that such kind of reasoning misses the following point of fundamental importance: “Converting” a traditional two-sided test of significance by inferring equivalence of the treatments under comparison from a nonsignificant result of the former, generally fails to yield a valid testing procedure.