Drug-drug interaction (DDI) studies are an important part of the regulatory drug development process. The US FDA, EMA and Japanese PMDA have issued guidance on the conduct of these DDI studies, however, a harmonised guidance is currently under review (ICH M12) and is expected to be adopted in April 2024. The risk of DDI can be assessed in vitro and data analysed using models of varying complexity. As identifying potential safety issues is the main purpose of these studies, many of the models have been developed to over-estimate the risk of DDI .This, however, needs to be balanced with the risk of false positives and the potential of unnecessary clinical DDI studies which are expensive and time consuming to perform. It is essential, therefore, to choose the most accurate model when analysing data from in vitro DDI studies.
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