Advances in Population Pharmacokinetics of Monoclonal Antibody Drugs.

BACKGROUND

Monoclonal antibody (mAb) drugs have become an important pillar of modern pharmaceutical fields. Owing to their high specificity and affinity, these drugs have shown broad application prospects in various fields, such as tumor therapy and autoimmune diseases. However, the pharmacokinetic profiles of mAbs are characterized by large individual differences that seriously affect drug efficacy and safety. Therefore, individualized drug delivery and therapeutic drug monitoring are key issues that must be addressed. Population pharmacokinetic (PPK) models contribute to therapeutic drug monitoring and provide a reference for individualized drug administration. Accordingly, the aim of this study was to review current PPK studies on mAb drugs and provide a reference for the clinical individualization of such drugs.

METHODS

PubMed and China Knowledge Network were searched for relevant original research articles published between 2017 and 2024, and 30 articles were selected for a detailed review based on their titles and abstracts. These included 15 articles in the final analysis, whereas other relevant articles were selected from the reference list.

RESULTS

Among these 15 studies, 6 optimized the dosing regimen using the established PPK model, 6 studies only established the PPK model and require further pharmacodynamic studies to optimize the dosing regimen, and 2 studies are currently in the clinical trial phase of the drug.

CONCLUSIONS

This review of advances in PPK studies of mAb drugs reviews current PPK studies on mAb drugs to inform the clinical individualization of such drugs.