The report of a bioequivalence study should give the complete documentation of its protocol, conduct and evaluation complying with Good Clinical Practice rules (see WHO Guideline for GCP for Trials on Pharmaceutical Products). The responsible investigator(s) should sign for their respective sections of the report. Names and affiliations of the responsible investigator(s), site of the study and 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 be given. The analytical validation report should be attached. Results of in vitro dissolution tests should be provided. In addition, the applicant should submit a signed statement confirming the identity of the test product with the pharmaceutical product which is submitted for registration.

All results should be presented clearly. 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, and facultatively also on a lin/log scale. All individual data and results should be given, also of eventually dropped-out subjects. Drop-out and withdrawal of subjects should be reported and accounted for. Test results of representative samples should be included.

The statistical report should be sufficiently detailed, so as 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.