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Application of model informed drug development in the field of antibody drug conjugates
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Bai-yang WU1, Ling WANG2, Jing JIANG1, 2, *
Acta Pharmaceutica Sinica | 2025, 60(2) : 288 - 299
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Acta Pharmaceutica Sinica | 2025, 60(2): 288-299
• Reviews •
Application of model informed drug development in the field of antibody drug conjugates
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Bai-yang WU1, Ling WANG2, Jing JIANG1, 2, *
Affiliations
  • 1. School of Pharmacy, Binzhou Medical University, Yantai 264003, China
  • 2. RemeGen Co., Ltd., Yantai 264006, China
Published: 2025-02-12 doi: 10.16438/j.0513-4870.2024-0787
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Antibody drug conjugates (ADC) have emerged as a cutting-edge technology in anti-tumor treatment, making significant strides in recent years. ADC couple a highly active small molecule toxin payload to highly specific antibodies through a linker, enabling precise targeting of tumor cells while reducing systemic toxicity, thereby expanding the therapeutic window. However, due to the complexity of ADC molecule design, its efficacy and safety are influenced by various factors. Model-informed drug development (MIDD) is a powerful tool that utilizes various mathematical models for modeling and simulation to conduct quantitative analysis, guiding drug development and decision-making. By integrating multi-faceted data and information using mathematical models, it is possible to gain insights into the complex mechanisms, pharmacokinetics, and pharmacodynamics of ADC, providing unique perspectives for optimizing ADC development processes and clinical translation decisions. This review will introduce the basic concepts of MIDD and ADC and discuss application cases of MIDD in different stages of ADC development, aiming to provide beneficial references for the advancement of ADC.

model informed drug development  /  antibody drug conjugate  /  modeling and simulation  /  pharmacokinetics/pharmacodynamics  /  quantitative systems pharmacology  /  physiologically based pharmacokinetics  /  population pharmacokinetics
Bai-yang WU, Ling WANG, Jing JIANG. Application of model informed drug development in the field of antibody drug conjugates[J]. Acta Pharmaceutica Sinica, 2025 , 60 (2) : 288 -299 . DOI: 10.16438/j.0513-4870.2024-0787
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Year 2025 volume 60 Issue 2
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Article Info
doi: 10.16438/j.0513-4870.2024-0787
  • Receive Date：2024-08-14
  • Online Date：2025-11-07
  • Published：2025-02-12
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  • Received：2024-08-14
  • Revised：2024-11-19
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Affiliations
    1. School of Pharmacy, Binzhou Medical University, Yantai 264003, China
    2. RemeGen Co., Ltd., Yantai 264006, China
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