The report on a bioequivalence study should give the complete documentation of its protocol, conduct and evaluation in compliance with the guidelines on good clinical practice (GCP) for trials on pharmaceutical products (5). The responsible investigator(s) should sign the respective section(s) of the report. The names and affiliations of the responsible investigator(s), the site of the study and the period of its execution should be stated. The names and batch numbers of the pharmaceutical products used in the study, as well as the composition(s) of the tests product(s), should also be given. The analytical validation report should be attached. The results of in vitro dissolution tests should be provided. In addition, the applicant for registration should submit a signed statement confirming that the test product is identical with the pharmaceutical product submitted.
All results should be clearly presented. The procedure for calculating the parameters used (e.g. AUC) from the raw data should be stated. Deletion of data should be justified. If results are calculated using pharmacokinetic models, the model and the computing procedure used should be justified. Individual plasma concentration-time curves should be drawn on a linear/linear scale, and may also be shown on a linear/log scale. All individual data and results should be given, including those for any subjects who have dropped out of the trial. Drop-out and withdrawal of subjects should be reported and accounted for. Test results on representative samples should be included.
The statistical report should be sufficiently detailed to enable the statistical analyses to be repeated, if necessary. If the statistical methods applied deviate from those specified in the trial protocol, the reasons for the deviations should be stated.