The in vivo QTc core assay: An evaluation of QTc variability, detection sensitivity and implications for the improvement of conscious dog and non-human primate telemetry studies
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The ICH S7B guideline describes the requirement to conduct an in vitro IKr (hERG) and in vivo QTc assay for human risk assessment of new drug products, but the guidance is devoid of recommendations on study execution or quality. In the absence of standard prac... ...
