From Classical PKPD to Model‐Informed Drug Development: Are “Digital Twins” a New Paradigm?

Quantitative pharmacology has guided drug development for decades, turning concentration and response data into mechanistic models that support dosing, trial design, and regulatory decisions. Model-informed drug development (MIDD) did not replace pharmacokinetic and pharmacodynamic (PKPD) modeling so much as formalize it across the lifecycle. Today, "digital twins" are often promoted as a new paradigm, yet most proposed features mirror established pharmacometrics: individual-level simulation, sequential updating, and decision-focused uncertainty analysis. The fundamentals remain unchanged, and identifiability still sets hard limits.