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 …

The liver is the largest internal organ of the body with complex microarchitecture and
function that plays critical roles in drug metabolism. Hepatotoxicity and drug-induced liver …

Background Conventional preclinical models often miss drug toxicities, meaning the harm
these drugs pose to humans is only realized in clinical trials or when they make it to market …

Nonclinical testing has served as a foundation for evaluating potential risks and
effectiveness of investigational new drugs in humans. However, the current two‐dimensional …

Recreating human organ–level function in vitro is a rapidly evolving field that integrates
tissue engineering, stem cell biology, and microfluidic technology to produce 3D organoids …

The liver, located in the right upper quadrant of the body and below the diaphragm, is
responsible for several functions, including primary detoxification of various metabolites …

Organs-on-chip (OoC), often referred to as microphysiological systems (MPS), are advanced
in vitro tools able to replicate essential functions of human organs. Owing to their …

Complex in vitro models (CIVM) offer the potential to improve pharmaceutical clinical drug
attrition due to safety and/or efficacy concerns. For this technology to have an impact, the …

Liver microphysiological systems (MPSs) are promising models for predicting hepatic drug
effects. Yet, after a decade since their introduction, MPSs are not routinely used in drug …

Previously, we provided an FDA/CDER perspective on nonclinical testing strategies and
briefly discussed the opportunities and challenges of using new approach methodologies …