Radhika Aitha

Quantitative Bridge or Black Box? A Practice-Based Framework for Statistical Programming Contributions to Population Pharmacokinetic/ Pharmacodynamic Modeling in Regulatory Drug Development

Population pharmacokinetic/pharmacodynamic (PK/PD) modeling now sits at the center of model-informed drug development (MIDD), shaping dose selection, labeling language, and regulatory submissions across therapeutic areas. Less attention goes to the statistical and clinical progra...