The use of genetically engineered cells for assessing CYP2D6-related polymorphic effects

As an example of advanced testing in the field of metabolism in an industri al environment, the introduction of some novel approaches, including the us e of genetically engineered cell lines for assessing CYP 2D6-related polymo rphic effects is illustrated. In this paper, it is demonstrated that novel in vitro test systems can be developed by using these genetically engineere d cell lines for evaluating the potential risks associated with proprietary drugs (especially if their metabolism depends to a high extent on CYP 2D6) . Moreover, it is demonstrated that, by the use of these in vitro methods, issues such as polymorphism, for which no animal models are available, can be assessed in such a way that predictions can be made on adverse effects w hich, up to now, could only be detected during clinical trials. Through the use of these new biotechnological in vitro metabolism models, clinically r elevant data can be obtained for a scientifically-based human risk assessme nt, and animal use can be reduced. (C) 2001 Elsevier Science Ltd. All right s reserved.