Praxbind: which tox species, and why?

“Toxicity studies with idarucizumab were performed in rats and rhesus monkeys. All studies in monkeys were conducted in the absence and presence of DE.”

“Dabigatran half-life of dabigatran is similar in rhesus and humans, while it is much shorter in rats. Furthermore, rhesus monkeys generate the active glucuronide metabolites of dabigatran, whereas in rats this is negligible.”

“Toxicity studies with idarucizumab were performed in rats and rhesus monkeys. All studies in monkeys were conducted in the absence and presence of DE.”

“Toxicity studies with idarucizumab were performed in rats and rhesus monkeys. All studies in monkeys were conducted in the absence and presence of DE.”

“It was also agreed that reproductive and developmental toxicity studies are not warranted taking into consideration the proposed used of idarucizumab on single days in emergency situations.”

“No genotoxicity, carcinogenicity, or reproductive toxicity studies have been conducted.”

“Toxicity studies with idarucizumab were performed in rats and rhesus monkeys. All studies in monkeys were conducted in the absence and presence of DE.”