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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.

Presented at OpenTox Euro 2018 in Athens, Greece.