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Although assessment of seizure risk is not a formal part of the core battery of CNS safety pharmacology studies described in the ICH guidance, many drug candidates are evaluated for seizure liability before clinical trials are initiated. Historically, these tests are conducted in live animals, usually mice. Due to a number of factors, including the 3Rs, time, and expense, use of in vitro tests for seizure liability is an attractive alternative to in vivo testing. You work for a small company trying to develop drugs to treat a variety of neuropsychiatric diseases. Several promising compounds have failed in vivo safety pharmacology tests because they reduced the seizure threshold. Your team has been working on a small molecule for treating generalized anxiety disorder. To avoid additional failures in in vivo safety pharmacology testing, the team decided to explore in vitro methods for assessing seizure liability at an earlier stage of drug discover/develoment. Which experimental model would you support, rat primary cortical cultures or hiPSC neurons?
SCIENCE
HEALTH SCIENCE
NURSING

 
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