CURRENT STATUS OF AND UNMET MODEL ASSAY NEEDS IN THE USE OF ALTERNATIVES IN BIOLOGIC SAFETY TESTING IN THE UNITED-STATES/

Pharmaceuticals, biologicals and medical devices are intended to have human exposure, and the first two are intended to also have biological effects. New additions to these categories of products can both confe r great benefits on society and produce significant profits for those who successfully bring them to market. But the development process for these is long and expensive, and the failure rate of candidates is hi gh. In vitro methods are now providing cost effective, time saving and scientifically sound tools for assessing the safety of candidate prod ucts at early stages when effectively integrated into the development process in a manner tailored for specific development cases.