In Vitro-In Vivo Extrapolation of Drug-induced Proarrhythmia Predictions at the Population Level

Drug cardiotoxicity is a serious issue for patients, regulators, pharmaceutical companies and health service payers because they are all affected by its consequences. Despite the wide range of data they generate, existing approaches for cardiac safety testing might not be adequate and sufficiently cost-effective, probably as a result of the complexity of the problem. For … Continued

Understanding CYP2D6 Interactions

Owing to the polymorphic nature of CYP2D6, clinically significant issues can arise when drugs rely on that enzyme either for clearance, or metabolism to an active metabolite. Available screening methods to determine if the compound is likely to cause drug-drug interactions, or is likely to be a victim of inhibition of CYP2D6 by other compounds … Continued

Combining Drug-disease and Economic Modeling to Inform Drug Development Decisions

Drug-disease models and clinical trial simulations are increasingly being used to support trial design and treatment optimization decisions. Less widely recognized is their potential for guiding strategic development decisions. These decisions require economic valuation of the potential product profile of efficacy, safety, ease of use, and so on. This review presents a disguised case study … Continued

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