PubMed · 4610836
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R M Ehrlich, J K Lattimer. 1974. Genitourinary tuberculosis.. https://pubmed.ncbi.nlm.nih.gov/4610836/
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The two-period cross-over design with two sequences of drug administration is a standard experimental design when bioequivalence of one test formulation is to be assessed in comparison with a reference formulation. Previously, an approach based on Fieller's confidence interval has been presented for the assessment of average bioequivalence under this particular design. However, the two-sequence two-period cross-over design is not very useful in the presence of unequal carry-over effects. Besides, this basic design does not provide independent estimators for the intra-subject variabilities. To overcome these limitations, it might be of interest to consider a higher-order cross-over design in which the number of periods and/or the number of sequences is greater than the number of formulations to be compared. Because of this, the present communication will concentrate on the generalization of Fieller's confidence interval concept for a particular group of higher-order cross-over designs. In addition to this, since the evaluation of simple average bioequivalence does not guarantee that the two products can be used interchangeably, the assessment of population and individual bioequivalence is addressed through the application of a comprehensible three-step decision rule. An example study with a two-sequence four-period design is also analysed to illustrate the use of the proposed methods.
New therapeutic measures in inflammatory bowel diseases (IBD) are either based on actual data on disease pathogenesis or on new pharmaceutic preparations of known drugs. An overshooting immune response with T cell activation in the local gut associated immune system seems to be central in the etiopathogenesis of IBD. Modulation of the antigenic load in the gut lumen by parenteral or enteral nutrition or antibiotic treatment can alter disease activity. Immunosuppressive drugs are able to decrease the overshooting immune response. Azathioprin has its clear value in chronic active steroid dependent disease courses of Crohn's disease. According to recent studies, Methotrexate seems to be active as well, however, more studies are necessary. Several studies were not able to prove that Cyclosporine is of value in the treatment of Crohn's disease. Newer preparations of aminosalicylates have shown effectiveness in both active disease and prolongation of remission in Crohn's disease in high doses. Local release formulations of steroids with high first-pass-effect as Budesonide will have their indication in subgroups of IBD patients. However, systemic steroid application is still the gold standard in active disease.
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