International STakeholder NETwork (ISTNET) Workshop for Creating a Developmental and Reproductive Toxicity (DART) Testing Roadmap for Regulatory Purposes

Advances in developmental biology, coupled with a high incidence of birth defects (3% annually in the US, higher incidence in low socio-economic countries; leading cause of infant deacth; Center for Disease Control), have prompted calls for increased tes&ng of chemicals, food addi&ves, and drugs for adverse impacts on human development. Current tes&ng paradigms for tes&ng for DART are very resource-intensive concerning &me, money, space and animals. Moreover, species differences might hamper their predic&ve value for humans. New methods (including in vitro human stem cell-derived models), hold great promise for more efficient and predic&ve models for DART and might be used in an integrated manner to solve regulatory challenges. In order to define a regulatory need for predic&ve models of DART and develop a road map for an integrated tes&ng strategy (ITS) for DART in the context of regulatory requirements, there needs to be truly effec&ve communica&on and discussion between various stakeholders (regulators, industry, and academia). To establish this, the first mee&ng of the Interna&onal STakeholder NETwork (ISTNET) DART is planned to build consensus on development and use of in vitro methods to deliver useful data for regulatory decisions.

FRITSCHE Ellen;  SELFA ASPIROZ Lucia;  ARAND Michael;  FAUSTMAN Elaine;  MULLER Iris; 

2025-01-09

SPRINGER INTERNATIONAL PUBLISHING AG

JRC139455

1868-8551 (online),   

https://www.altex.org/index.php/altex/article/view/2875,    https://publications.jrc.ec.europa.eu/repository/handle/JRC139455,   

10.14573/altex.2410081 (online),