Integrated testing strategy of pharmaceutical intermediates for occupational health

Abstract

In order to assess the occupational health hazard of intermediates (IM), hazard data were traditionally generated through experimental animal testing, which are more and more replaced by alternative methods considering animal welfare and costs. Indeed, there are a number of other ways to assess the health hazards: comparing substances with similar structures, grouping them together into logical categories, doing specialized computer modelling, using weight of evidence approach (WoE) and integrated testing strategy (ITS). We have evaluated the current state of scientific knowledge from the literature and from in silico evaluation tools. We have proposed new ITS for Novartis Pharma own pharmaceutical IM for occupational health purposes which defines the tiered approach in performing in silico, in vitro and in vivo studies which support risk management to prevent workplace diseases that could be triggered by IM and reduces the number of in vivo tests required.