Bioequivalence and Bioavailability Forum

❝ My angle on this was related. FDA recently issued a PSG for Beclo/Calcipotriol introducing the need for a pilot trial.

This is this occult skin bleaching (vasocontrictor) test, here you don't "ship" any samples at all.

Ladies, these backup samples are for reproducing results in case the primary analysis is fishy. And to stop labs from making up studies and results completely (with mixed results on this part). I would keep this in mind when planning a trial.

If you are in doubt, start a controlled correspondence with the-one-not-to-be-named (aka USA-FDA-Trump-whatever...)