In vitro tests in screening teratogens: considerations to aid the validation process

The need for improving the process of assessing teratogenic hazards has led to an increased interest in the potential for using in vitro systems as screens of developmental toxicity. The Consensus Workshop on In Vitro Teratogenesis Testing addressed many of the basic questions relative to the development and validation of these systems, and stressed the need to establish a well-controlled approach to that validation process [Kimmel et al, 1982]. It is obvious that this process has just begun and that considerable work remains. This paper indicates some of the areas that should be addressed in any in vitro study relative to experimental design and data reporting that may be helpful to that process.