Presentation of results from bioequivalence studies.
Based on 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 single-dose 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/time data and the various steps of calculation. This would speed up peer review and ultimately improve and harmonize the standard of bioequivalence publications.
Sauter
R
R
Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.
Steinijans
V W
VW
Diletti
E
E
Böhm
A
A
Schulz
H U
HU
D000328:Adult; D003627:Data Interpretation, Statistical; D006801:Humans; D008297:Male; D012016:Reference Values; D012107:Research Design / Q000592:standards*; D013806:Theophylline / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
D013806:Theophylline