Recarbrio: which tox species, and why?

“In 1- and 3-month repeated-dose toxicology studies, relebactam produced only limited toxicity. Two dose-dependent toxicities with clinical relevance were CNS toxicity primarily in rats and minimal kidney toxicity primarily in monkeys.”

“The selection was based on the in vitro and in vivo metabolic profiles and the demonstration of satisfactory pharmacokinetics in these species. The monkey had previously been used as the non-rodent species for the assessment of toxicological profile of imipenem/cilastatin including the evaluation of renal toxicity caused by imipenem.”

“Relebactam was evaluated in repeat-dose toxicity studies in rats (4 weeks with 4 weeks recovery, and 12 weeks with no recovery phase) and in monkeys (4 weeks with 4 weeks recovery, and 12 weeks with no recovery phase).”