“The pivotal repeat-dose toxicity studies with tafamidis were conducted in rats for up to 26 weeks of oral dosing and in dogs for up to 39 weeks of oral dosing.”
✓ VerifiedFDA pharmacology/toxicology review, p. 13Source ↗
Why that species
Rat and dog expected to show a pharmacologic response to tafamidis similar to humans
“These findings add relevance to the rat, rabbit and dog toxicology studies as they can be expected to exhibit a similar pharmacologic response to tafamidis as in humans.”
✓ VerifiedFDA pharmacology/toxicology review, p. 21Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“The pivotal repeat-dose toxicity studies with tafamidis were conducted in rats for up to 26 weeks of oral dosing and in dogs for up to 39 weeks of oral dosing.”
✓ VerifiedFDA pharmacology/toxicology review, p. 13Source ↗