Presentation of results from bioequivalence

Author(s): Steinijans, V., Diletti, E., Böhm, A., Schulz, H.

Journal/Book: International Journal of Clinical Pharmacology, Therapy and Toxicology. 1992; 1: 7-30.

Abstract: Based an general guidelines and requirements for the design and analysis of bioequivalence studies, specific recommendations are made for the presentation of results, both in tabular and graphical form. This is done by means of two examples, one of a singledose study and one of a multiple-dose study. The recommendations in this paper are twofold. Firstly, a complete and rather detailed presentation of results is given, which practically corresponds to the standard of research reports. Secondly, a subset of this is suggested for publication. It gives the essential results for bioequivalence assessment in a standardized form. From an editorial point of view, it would be highly appreciated if the papers submitted for publication were always accompanied by a complete presentation including the individual concentration/tune data and the various steps of calculation. This would speed up peer review and ultimately improve and harmonize the standard of bioequivalence publications.

Keyword(s): Bioequivalence

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