STRATEGIES FOR THE APPLICATION AND INTEGRATION OF IN-VITRO METHODS TOTHE DEVELOPMENT OF NEW PHARMACEUTICALS AND MEDICAL DEVICES

Pharmaceuticals and medical devices are intended to have human exposur e and/or contact, and at least pharmaceuticals are intended to also ha ve biological effects. New additions to these categories of products c an both confer great benefits on society and produce significant profi ts for those who successfully bring them to market. But the developmen t process for these is long and expensive, and the failure rate of can didates is high. In vitro methods can provide cost effective, time sav ing and scientifically sound tools for assessing the safety of candida te products at early stages when effectively integrated into the devel opment process in a manner tailored for specific development cases.