DART Testing Strategies for Human Pharmaceuticals: Animal Models vs In-Vitro Approaches

For years there has been ongoing research into new approaches enabling alternative methods to replace
animal studies. In the area of reproductive toxicity testing, a number of research programmes have
provided important test strategies with regard to in-vitro testing methods.
The data might be insufficient to reach a complete replacement of in-vivo studies regarding developmental
and reproductive toxicity (DART) by in-vitro approaches currently. However, it could be expected that the
tests and combined test batteries developed and studied may contribute to alleviating the need for some
of the animal studies required for reproductive testing (embryo-foetal toxicity) under ICH S5A guidelines.
In order to achieve this goal, discussions between regulators, industry and the academic scientists
involved are needed. An important aspect is the long time it takes to implement changes from this work on alternatives into regulatory measures