PBPK modelling for first-in-human predictions
22 February 2019
Physiologically based pharmacokinetic (PBPK) modelling is a valuable tool for drug discovery and development and is accepted by regulatory agencies for the prediction of drug-drug interactions. However, PBPK modelling can be utilised for a wider range of pharmaceutical applications. A recently published review article in Clinical Pharmacokinetics, “Physiologically Based Pharmacokinetic Modelling for First‑In‑Human Predictions: An Updated Model Building Strategy Illustrated with Challenging Industry Case Studies”, provides an updated strategy for first-in-human PBPK modelling by integrating new ADME knowledge and proposing decision trees for each essential component of a first-in-human prediction. In addition, the article describes four industry case studies for more challenging compounds highlighting key components of the strategy.
One of our scientists, Dr Aki Heikkinen, has contributed to the article in addition to other pharma industry PBPK modelling experts Neil Miller, Micaela Reddy, Viera Lukacova and Neil Parrot. The article is a must-read for everyone interested in PBPK modelling and its applications in drug discovery and development.