Formulation and Quality – Chemical
End-to-End Hot Topic
Biopharmaceutics provides the link between CMC activities and product performance in the patient, i.e. achievement of the intended therapeutic outcomes. Biopharmaceutics risk assessment is a key element of drug product development, influencing formulation approach, manufacturing strategy and clinical study design, and underpinning a clinically relevant control strategy at registration. This presentation will describe the application of the BioRAM (Biopharmaceutics Risk Assessment Roadmap) approach, an innovative strategy and framework for patient-centric drug development. BioRAM is a systems approach, which brings together scientists from across pharmaceutics, manufacturing, clinical and preclinical disciplines to perform an integrated biopharmaceutics risk assessment. This can be used to drive product development activities, with the goal of optimizing product performance for patient benefit.