For decades, preclinical toxicology was essentially a descriptive discipline in which
treatment-related effects were carefully reported and used as a basis to calculate safety …

After multiple drugs were removed from the market secondary to drug‐induced torsade de
pointes (TdP) risk, the International Council for Harmonisation (ICH) released guidelines in …

Animal testing is used in pharmaceutical and industrial research to predict human toxicity,
and yet analysis suggests that animal models are poor predictors of drug safety in humans …

Although lack of efficacy is an important cause of late stage attrition in drug development the
shortcomings in the translation of toxicities observed during the preclinical development to …

Attrition due to nonclinical safety represents a major issue for the productivity of
pharmaceutical research and development (R&D) organizations, especially during the …

Human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CM) are commercially
available, and cardiac differentiation established routine. Systematic evaluation of several …

Defining an appropriate and efficient assessment of drug‐induced corrected QT interval
(QTc) prolongation (a surrogate marker of torsades de pointes arrhythmia) remains a …

Abstract The ICH E14/S7B Questions and Answers (Q&As) guideline introduces the concept
of a “double negative” nonclinical scenario (negative hERG assay and negative in vivo QTc …

The content of this article derives from a Health and Environmental Sciences Institute (HESI)
consortium with a focus to improve cardiac safety during drug development. A detailed …

Given that cardiovascular safety concerns remain the leading cause of drug attrition at the
preclinical drug development stage, the National Center for Toxicological Research of the …