Study confirms the predictability of nonclinical models to humans, and show that preclinical data together with a carefully designed and monitored SAD study may provide reliable information for an early and science-based development decision.
AZD9272 and AZD2066 show lack of NMDA antagonist psychoactive effects but do share discriminative (psychoactive) effects with MTEP, a selective mGluR5 antagonist. Data suggest a specific psychoactive effect of mGluR5 antagonists.
A timely start of preclinical assessment of drug abuse and dependence liability is essential to keep options open to redirect, deselect and characterize drug candidates. It's not just a matter of meeting regulatory demands and timelines but creating room for improvement and reducing late attrition.
"On 23 July 2013, the US Food and Drug Administration (FDA), the Health and Environmental Sciences Institute (HESI) and the Cardiac Safety Research Consortium (CSRC) presented a new paradigm for cardiotoxicity testing, with a lofty goal of validating and standardizing the new assays in 2 years' time
Three interesting articles in the last NRDD issue: One on drug attrition, one on 2013 FDA approval, and one the CSRC-HESI-FDA workshop on QT.