Fetroja: which tox species, and why?

“The clinical formulation of cefiderocol, was tested in the repeat-dose toxicology studies described below. Rats and monkeys were the primary rodent and nonrodent species used in toxicology testing of this drug product.”

“In the response, the Applicant explained that in exploratory single-dose studies in dog, vomiting was observed several times from during dosing to 1 hour after the end of dosing at 1000 mg/kg, reason for which the Applicant considered that dogs would not tolerate repeat-dosing at the 1000 mg/kg dose level.”

“The clinical formulation of cefiderocol, was tested in the repeat-dose toxicology studies described below.”