Decision analysis and bioequivalence trials
نویسندگان
چکیده
منابع مشابه
Bioequivalence Trials, Intersection–Union Tests and Equivalence Confidence Sets
The bioequivalence problem is of practical importance because the approval of most generic drugs in the United States and the European Community (EC) requires the establishment of bioequivalence between the brand-name drug and the proposed generic version. The problem is theoretically interesting because it has been recognized as one for which the desired inference, instead of the usual signifi...
متن کاملBioequivalence Trials, Intersection-union Tests, and Equivalence Conndence Sets
The bioequivalence problem is of practical importance because the approval of most generic drugs in the United States and the European Community (EC) requires the establishment of bioequivalence between the name brand drug and the proposed generic version. The problem is theoretically interesting because it has been recognized as one for which the desired inference, instead of the usual signiic...
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In the current EMA guidance it is stated that in principle, evaluation of bioequivalence should be based upon measured concentrations of the parent compound (also for inactive pro-drugs) as the Cmax of the parent compound is usually more sensitive to detect differences in absorption rate than the Cmax of the metabolite. Only for some pro-drugs with very low plasma concentrations and quickly eli...
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Unlike traditional approaches, Bayesian methods enable formal combination of expert opinion and objective information into interim and final analyses of clinical trial data. However, most previous Bayesian approaches have based the stopping decision on the posterior probability content of one or more regions of the parameter space, thus implicitly determining a loss and decision structure. In t...
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ژورنال
عنوان ژورنال: Statistical Science
سال: 1998
ISSN: 0883-4237
DOI: 10.1214/ss/1028905932