Implementation of in vitro replacement technologies in regulatory drug testing - An innovation systems perspective

Abstract

The replacement of in vivo methods by in vitro methods in regulatory drug testing is rare. The aim of this research is to identify barriers and drivers of the replacement of in vivo methods by in vitro methods in Europe. We studied two cases. The first case is the Draize eye test. Since 2009, the in vivo test is partly replaced by in vitro methods. The second case concerns EPO potency testing. Since the eighties, financial and scientific efforts have been made to replace the in vivo EPO potency test with in vitro methods; however the efforts failed to deliver expected outcomes. The innovation systems approach is used to identify the drivers and barriers regarding replacement of in vivo methods by in vitro methods in regulatory drug testing in Europe, such as the presence or absence of legislative pressure, legitimacy, and funding. Combining and comparing the outcomes resulted in an overview of potential barriers and drivers, and an indication of which of these factors are critical for replacement of in vivo methods by in vitro methods in regulatory drug testing. Policy makers could use these results to formulate policies that enable the replacement of in vivo methods by in vitro methods in regulatory drug testing.