[Statistical tests for bioequivalence].
The application of statistical tests of hypotheses in the evaluation of bioavailability studies is discussed. The necessity of correctly indicating the risk of false decisions in accordance with the hypothesis to be tested is emphasized. The procedure of evaluation presented here is performed analogously to the methods of the statistical quality control and always takes errors of the 1st kind and the 2nd kind into account. The advantageous use of the operating characteristic is pointed out. It is possible to read from these curves the effects which the size of the random sample and the experimental variation have on the reliability of the statement. The procedure is illustrated by means of numerical examples from literature.
D001682:Biological Availability; D011897:Random Allocation; D013223:Statistics as Topic; D013810:Therapeutic Equivalency
Uber das statistische Testen der Bioäquivalenz.