Strengthening confidence in modelling approaches to support better-informed medicine development

A recent study on the “Differences in Physiologically Based Pharmacokinetic Predictions between Software Platforms Can Be Clinically Relevant: Cases of Levornestrogel and Ethinylestradiol Concentrations with SIMCYP versus PK-Sim from a User Perspective” sheds light on the impact that differences between physiologically based pharmacokinetic (PBPK) modelling platforms can have on predicted drug concentrations. Published in the European Journal of Drug Metabolism and Pharmacokinetics, the article explores how variations between two widely used platforms, SIMCYP and PK-Sim, may influence pharmacokinetic predictions and their interpretation.

Physiologically based pharmacokinetic modelling has become an increasingly valuable tool in medicine development, supporting the prediction of drug behaviour, the optimisation of clinical strategies, and regulatory decision-making. However, differences in software platforms, model implementation, and underlying assumptions can influence simulation outcomes, highlighting the importance of methodological transparency and appropriate model evaluation.

The findings of this study are particularly relevant to ERAMET’s ongoing efforts to improve the reliability of model-informed approaches in medicine development. By examining differences between PBPK platforms, the article provides valuable insights into how variations in modelling tools can influence predicted drug concentrations and reinforces the importance of transparency and consistency in their application. 

Using levonorgestrel and ethinylestradiol as case studies, the authors compare PBPK predictions generated using SIMCYP and PK-Sim, demonstrating how differences between platforms may lead to clinically relevant variations in predicted exposure. The study therefore reinforces the importance of understanding model assumptions and ensuring robust evaluation when applying PBPK approaches to support regulatory and clinical decisions.

ERAMET promotes the responsible uptake of reliable and transparent modelling tools to support more efficient and scientifically robust development processes. In line with these objectives, the publication highlights the importance of consistency, transparency,and confidence in model-informed approaches.

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