Abstract Model-based approaches, including population pharmacokinetic-
pharmacodynamic modeling, have become an essential component in the clinical phases of …

The purpose of precision dosing is to increase the chances of therapeutic success in
individual patients. This is achieved in practice by adjusting doses to reach precision dosing …

Introduction Continuous glucose monitoring (CGM) devices capture longitudinal data on
interstitial glucose levels and are increasingly used to show the dynamics of diabetes …

While only a fraction of the worldwide population may have a particular rare disorder,
millions of people worldwide are affected across the over 6,000 rare disorders and do not …

Model‐informed dose selection has been drawing increasing interest in oncology early
clinical development. The current paper describes the example of FGF401, a selective …

Adaptive designs are increasingly developed and used to improve all phases of clinical
trials and in biomedical studies in various ways to address different statistical issues. We first …

The main goal of the treatment for acute myocardial infarction is to achieve reperfusion of the
affected myocardial tissue, with percutaneous coronary angioplasty being the gold standard …

Project Optimus is a major FDA initiative aimed at ensuring dose optimization in oncology
drug development, moving away from the maximum tolerated dose paradigm and …

Interspecies scaling of the pharmacokinetics (PK) of CB 4332, a 150 kDa recombinant
complement factor I protein, was performed using traditional and model-based approaches …

The rising cost in drug development has led to continuous calls for more efficient and
powerful design optimization and analysis tools for pkpd studies. More sophisticated models …