Bio-Equivalence : Module 10


The report of a bioequivalence study should give the complete documentation of its protocol, conduct and evaluation complying with good clinical practice rules. The relevant ICH guideline (E3) can be used in the preparation of the study report. The responsible investigator(s) should sign 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. Results of in vitro dissolution tests should be provided. In addition the applicant should submit a signed statement confirming that the test product is identical to the pharmaceutical product which is submitted for registration.

The bioanalytical validation report should be attached. The bioanalytical report should include the data on calibrations and quality control samples. A representative number of chromatograms or other raw data should be included covering the whole calibration range, quality control samples and specimens from the clinical trial.

All results should be presented clearly. All concentrations measured in each subject and the sampling time should be tabulated for each formulation. Tabulated results showing API concentration analyses according to analytical run (including runs excluded from further calculations, including all calibration standards and quality control samples from the respective run) should also be presented.

The tabulated results should present the date of run, subject, study period, product administered (multisource or comparator) and time elapsed between drug application and blood sampling in a clear format. The procedure for calculating the parameters used (e.g. AUC) from the raw data should be stated. Any deletion of data should be justified.

If results are calculated using pharmacokinetic models, the model and the computing procedure used should be justified. Individual blood concentration/time curves should be plotted on a linear/linear and log/linear scale. All individual data and results should be given, including information on those subjects who dropped out.

The drop-outs and/or withdrawn subjects should be reported and accounted for. Results of all measured and calculated pharmacokinetic parameters should be tabulated for each subject–formulation combination together with descriptive statistics. 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.

Dr. Manoj Karwa


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