Bioequivalence and Bioavailability Forum

❝ Yes, that’s a reasonable design, with the exeption that you should apply a six sequence design. For details see this post.

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❝ If in a later stage you go for a pivotal study you should consult the regulatory agency, since e.g., some European regulators want to see for such a design (2 test formulations) a Bonferroni-corrected confidence interval (95% instead of 90%) in order to keep the patient’s risk at 5% (EMEA’s Points to Consider on Multiplicity Issues in Clinical Trials).

Dear Sir,
Thank you for this information and I want to ask you something else. I just found that our client want in the bioequivalence study to compare the higher strength for the test with the same strength of the reference marketed in Europe versus USA. Is this possible? In the bioequivalence guidelines is specified that the reference must be the innovator. I did not found other 3 way crossover studies to investigate this. Thank you.