Just read a pharmacology study (this one – yes, more marijuana research) testing bioequivalence for a new formulation of a drug. In addition to being a solution rather than a capsule, the new formulation contained only 85% as much of the active ingredient.
The maximum concentration reached with the new version? 82.5% of the maximum concentration reached with the old version. And only 77.3% for the active metabolite. (Those are point estimates; the 90% confidence intervals maxed out at 91.2% and 82.5%, respectively. These are all estimates of the geometric-mean ratio between the two, BTW.) So basically, it looks like you’d expect from the slightly smaller dose, if things were linear in dose.
But they concluded that the two formulations were equivalent, since the numbers, although lower, were within the FDA ranges for establishing bioequivalence.
I got nerd-sniped by wondering if you could actually fallacy-of-composition this into establishing that 0% of the original dose was equivalent to 100%, via a series of studies with declining doses. It turns out that the FDA standards are complicated (1, 2), and I’m still not sure whether you could. But still, WTF??


