Pioneering pharmacometrics practice in Korea: an eight-year retrospective analysis of 192 projects from the first dedicated service organization (2016-2024).

Abstract

Pharmacometrics has become a pivotal component of drug development and regulatory science in Korea, evolving from traditional pharmacokinetic (PK)/pharmacodynamic (PD) modeling to advanced approaches such as physiologically based pharmacokinetic (PBPK) modeling and quantitative systems pharmacology (QSP). This study reviews 192 pharmacometrics projects conducted between 2016 and 2024 by Korea's first pharmacometrics service company, covering diverse modalities, indications, and development stages. Key applications included first-in-human dose prediction, clinical trial design, and patient population-specific PK/PD modeling, with systematic tracking of regulatory outcomes and publications. While oncology remained the dominant therapeutic area, recent projects expanded into gene therapy, GLP-1 agonists, pediatric orphan indications, and advanced biologics including antibody-drug conjugates, bispecific antibodies, and engineered fusion proteins-using PBPK and semi-mechanistic models. These case-driven analyses highlight the growing regulatory impact and strategic value of pharmacometrics. As the field moves into a new era shaped by artificial intelligence/machine learning integration and Food and Drug Administration-driven new approach methodologies initiatives, this review not only reflects on past practices and achievements but also provides strategic perspectives to guide the future direction of pharmacometrics in Korea.