Quantitative approaches to drug development

The FDA recently announced its plans to reduce animal testing in preclinical studies in favour of more effective, human-relevant methods, using a range of New Approach Methodologies (NAMs). To help drug developers to navigate this new paradigm, our QSP Scientific Lead Lourdes Cucurull-Sanchez has co-authored a paper outlining how and when Quantitative Systems Pharmacology (QSP) among other in silico tools, can be used to phase out animal testing in a cost-efficient, timely and reliable way.

Pharmacometrics, a relatively young discipline using model-based methods for drug development, plays a vital role in internal decision-making and health authority interactions. However, the demand for skilled pharmacometricians currently exceeds the supply provided by academic institutions. Elodie Plan and Mats Karlsson took part in a group of experts, assembled by Peter Bonate, to provide insights in a publication in the…

The prediction-corrected visual predictive check (pcVPC) is a commonly used model diagnostic, especially in the context of heterogeneous study designs or adaptive dosing. While useful, the transformation applied in prediction correction can result in plots that are unintuitive and difficult to interpret — even for experienced modelers.