Bioequivalence and Bioavailability Forum

❝ We are planning to conduct a bioequivalence study for submission in Egypt. The molecules of interest necessitate a washout period of approximately three months in a crossover design. Should we perform re-screening/interim safety analysis before the dosing of Period II?

For Studies on drugs with long elimination half-lives, Egyptian guideline for conducting bioequivalence studies for marketing authorization of generic products states that "Normally the interval between study days should not exceed 3 – 4 weeks." I recommend opting for a parallel design instead of a crossover design with a washout period of three months. This approach will also eliminate the need for re-screening.

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Reference: Egyptian Drug Authority, Central Administration of Pharmaceutical Products. Egyptian Guidelines on Conducting Bioequivalence Studies for Marketing Authorization of Generic Products. Cairo. February 2017. Online.
[Helmut]

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