Safety pharmacology satisfies a key requirement in the drug development process, assessing any potential adverse effects that drug candidates may have on the body’s major physiological systems. To this end, the regulatory guidelines (ICH S7A/S7B) require that a core battery of safety pharmacology studies be conducted with an investigational drug before first administration to humans, to analyze the drug’s effect on cardiovascular, respiratory and central nervous system function. The typical core battery of safety pharmacology studies includes:
Central nervous system studies: Irwin test
Cardiovascular system studies:
In conscious or anesthetized animals
HERG and Purkinje studies (in vitro)
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