The assessment of bioequivalence in a two-period cross-over design: development of a simple BASIC program.
The complete algorithms needed in the calculation of confidence intervals on the basis of observations from a two-way cross-over bioequivalence trial are described. They do not contain assumptions as to the expected sampling distribution or possible period effects. The algorithms were used in a BASIC program, which was developed subsequently. Its validity is demonstrated here with a set of literature data. The program is available from the authors upon request.
SK&F Institute for Applied Clinical Pharmacology, Smith Kline Dauelsberg GmbH, Göttingen, F.R.G.
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Meineke
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de Mey
D000465:Algorithms; D016001:Confidence Intervals; D008838:Microcomputers; D011336:Probability; D011381:Programming Languages; D012984:Software; D013810:Therapeutic Equivalency