Streamlined Pathways to Clinical Success through Integrated Modelling

Recently, model informed drug development (MIDD) has gained more popularity, with its value recognized by regulatory bodies. Here, we present case studies on how integrated modelling can provide streamlined pathways to clinical success through dose-selection and alternative routes of determining bioequivalence. The introduction of FDA’s Project Optimus has highlighted the role MIDD can play in finding a safe but efficacious dose for patients within the field of Oncology. We illustrate how a semi-mechanistic model linking pharmacokinetics (PK), pharmacodynamics (PD) and tumour response (TGI) can predict the response rate of a given dose, and thus select an efficacious dose. MIDD has also gained interest for long-acting injectable products, where bioequivalence trials are extremely challenging due to extended-release profiles. We illustrate how a population PK model can be used to test a large number of virtual formulations, and thus propose bioequivalent products. These case-studies demonstrate how MIDD can increase clinical success.