Paxlovid: which tox species, and why?

“Pivotal repeat-dose toxicology studies were conducted in rats (2-week and 1-month durations) up to 1000 mg/kg/day and in monkeys (15-day and 1-month durations) up to 600 mg/kg/day.”

“The species used for the GLP compliant pivotal studies included rats and monkeys based on similar PK profile seen in these species compared to human. Furthermore, the pharmacological target of PF-07321332 is an exogenous entity (virus-specific protein) and therefore there are no pharmacologically relevant species.”

“Pivotal repeat-dose toxicology studies were conducted in rats (2-week and 1-month durations) up to 1000 mg/kg/day and in monkeys (15-day and 1-month durations) up to 600 mg/kg/day.”