While targeted radiation therapies (TRTs) are seeing increasing interest in the oncology space, the regulatory landscape continues to evolve leaving development teams without clear guidance. Model-Informed Drug Development (MIDD) can provide key insights into optimizing doses to achieve maximum efficacy within safety bounds, as well as the design of novel therapeutics with enhanced therapeutic index. The theranostic nature of TRTs allows for precise modeling and prediction of drug kinetics and absorbed doses which will allow for better decision-making in the development process. Here we present an end-to-end framework for using MIDD with TRTs, specifically with PSMA targeting radio-ligands.
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