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

Neurotoxicity and developmental neurotoxicity are important issues of chemical hazard
assessment. Since the interpretation of animal data and their extrapolation to man is …

Multiple non-animal-based test methods have never been formally validated. In order to use
such new approach methods (NAMs) in a regulatory context, criteria to define their …

Pharmaceuticals intended for use in patients of childbearing potential need to be tested for
teratogenicity before marketing. Several pharmaceutical companies use animal-free in vitro …

The call for a paradigm change in toxicology from the United States National Research
Council in 2007 initiates awareness for the invention and use of human‐relevant alternative …

Test systems to identify developmental toxicants are urgently needed. A combination of
human stem cell technology and transcriptome analysis was to provide a proof of concept …

Millions of children are born each year with a birth defect. Many of these defects are caused
by environmental factors, although the underlying etiology is often unknown. In vivo …

Hazard assessment, based on new approach methods (NAM), requires the use of batteries
of assays, where individual tests may be contributed by different laboratories. A unified …

There is evidence that chemical exposure during development can cause irreversible
impairments of the human develo** nervous system. Therefore, testing compounds for …

Stem cell-based in vitro test systems can recapitulate specific phases of human
development. In the UKK test system, human pluripotent stem cells (hPSCs) randomly …