Target organ profiles in toxicity studies supporting human dosing: does severity progress with longer duration of exposure? Regulatory Tox. Pharm., 73, 737-746.
We have previously reported the profile of target organs (defined as organs showing histopathological changes) in rodent and non-rodent toxicity studies conducted prior to first-time-in-man (FTiM) for 77 AstraZeneca candidate drugs (CDs). Here, we test the assumption that toxicity is exacerbated by dosing duration by comparing the incidence and severity of target organ toxicities in these ≤ 6 week FTiM studies with those observed in subsequent subchronic/chronic (≥ 3 month) studies…
By Chloe Atkinson|2022-11-28T14:11:15+00:00June 17th, 2021|Comments Off on Target organ profiles in toxicity studies supporting human dosing: does severity progress with longer duration of exposure? Regulatory Tox. Pharm., 73, 737-746.