Welireg: which tox species, and why?

“The safety of belzutifan was evaluated in GLP-compliant repeat-dose toxicology studies up to 3- month duration in rats and dogs using the intended oral route of administration.”

“It can be concluded that especially dogs and to a lesser extent rats exhibit a similar pharmacokinetic profile of belzutifan compared to humans and are therefore appropriate for toxicological assessment of belzutifan.”

“The safety of belzutifan was evaluated in GLP-compliant repeat-dose toxicology studies up to 3- month duration in rats and dogs using the intended oral route of administration.”