Palsonify: what was done before first-in-human, and what came after?

The public FDA and EMA reviews of Palsonify don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

Find the highest dose with no adverse effects (NOAEL) in each animal species, convert it to a human equivalent dose, usually by body surface area, pick the most appropriate species, then divide by a safety factor (default 10) to get the maximum recommended starting dose.

NOAEL / key findings: Dog NOAEL 10 mg/kg/day (3x MRHD) for nervous system effects; tremors only at 75 mg/kg/day (~23x MRHD) (FDA integrated review, p. 87)

Full method, every step sourced →