PBPK based approach towards risk assessment

Barbara Wiśniowska, Assistant Professor, Jagiellonian University Medical College, Krakow, Poland

For several decades the Physiologically-Based Pharmacokinetic (PBPK) Modelling has evolved from a scientific endeavour into an integral tool in drug discovery and development and recently reached the point where it is actively encouraged by global regulators. PBPK models are routinely applied throughout a drug’s lifecycle. They support crucial go/no-go decisions, help to design clinical trials or support clinical trial waiver requests and inform drug labels.