Bioequivalence and Bioavailability Forum

Dear Madam,

why are you shouting at us?

❝ For Canadian submission, can we consider the Fully replicated crossover design with two-stage sequential approach for BE study?

ElMaestro correctly wrote above that no method is published yet. Note that currently HC does not accept refe­rence-scaling. In June 2014 the “Scientific Advisory Committee on Pharmaceutical Sciences and Cli­nical Pharmacology” recommended FDA’s method for implementation but is considering other approaches as well. Let’s see.
If you want to explore RSABE in a TSD with current hard-/software finding and validating an adjusted α would take ~six years. If you believe in Moore’s law (processing power doubles every 18–24 months) and you buy always the fastest available machine it would still take ~1½ years to get a result. Unless you find someone who is able to write some fancy C- or FORTRAN-code for a massive parallel super­computer (which will cost you a fortune) I don’t see a realistic way out.

If you want to run a fully replicate design for conventional ABE (no scaling) IMHO that should be doable. Start your own simulations.

❝ and how TPD will look at this?

With great interest. Report back their response.