Xiangya Quantitative Pharmacology is deeply rooted in the strong academic foundations of the Xiangya system in clinical pharmacology. Under the leadership of Professor Zhou Honghao, Academician of the Chinese Academy of Engineering and a pioneer of pharmacogenetics and pharmacogenomics in China, Xiangya clinical pharmacology has, since the 1980s, developed a distinctive and systematic academic profile in the field of individualized and precision drug therapy. Guided by Academician Zhou Honghao’s core philosophy of “individualized medication,” scholars such as Professor Cheng Zeneng and Professor Yang Guoping, building upon the intellectual framework of Xiangya clinical pharmacology, have responded to the needs of drug development and clinical practice by adopting modern quantitative pharmacology modeling approaches, including population pharmacokinetics (PopPK), physiologically based pharmacokinetics (PBPK), physiologically based biopharmaceutics modeling (PBBM), quantitative systems pharmacology (QSP), and artificial intelligence (AI). These efforts have driven the transformation and advancement of modeling paradigms, leading to the establishment of a full-chain research system characterized by quantitative pharmacology modeling and encompassing basic science and methodological research, platform development, and clinical translation, thereby serving both drug development and precision clinical pharmacotherapy.

The core members of the team include Professor Yang Guoping, Professor Cheng Zeneng, Professor Pei Qi, Professor Xie Feifan, Associate Researcher Peng Jinfu, Distinguished Associate Professor Yang Liang, Assistant Researcher Kuang Yun, and Lecturer Liu Feiyan. In addition, faculty members from the Institute of Clinical Pharmacology of Central South University and three affiliated hospitals—including Professor Ouyang Dongsheng, Professor Zuo Xiaocong, and Professor Yan Miao, among others—have also conducted related research and clinical applications in quantitative pharmacology. Many team members have pursued doctoral training, visiting scholarships, or collaborative research at internationally renowned quantitative pharmacology platforms, such as the U.S. Food and Drug Administration (FDA), the University of Washington (Seattle), the University of Pennsylvania, the University of Otago (New Zealand), Uppsala University (Sweden), Leiden University (the Netherlands), and Ghent University (Belgium). Relying on research platforms such as the National–Local Joint Engineering Laboratory for Drug Clinical Evaluation Technology and the Hunan Engineering Technology Research Center for Drug Formulation Optimization and Early Clinical Evaluation, the team has established a comprehensive research system integrating basic research, engineering-oriented modeling platform development, and clinical application. The team places strong emphasis on the cultivation of young talent and has trained more than 30 PhD and master’s graduates in quantitative pharmacology to date, some of whom have become key contributors in universities, hospitals, pharmaceutical companies, and regulatory agencies in China and abroad.

In terms of scientific research and clinical studies, the team has led more than 40 national and provincial research projects, including National Major New Drug Innovation Programs, National International Science and Technology Cooperation Projects, National Natural Science Foundation of China (NSFC) grants, and Hunan Provincial Science and Technology Key Projects, and has cumulatively completed more than 800 Phase I clinical studies. In recent years, the team has been awarded 11 NSFC projects in quantitative pharmacology (4 Young Scientist projects and 7 General Program projects), ranking among the leading groups in domestic universities.

The team has achieved a series of accomplishments in quantitative pharmacology platform development and methodological innovation. It led the development of the world’s first digital “genetic portrait” system platform for precision dosing (selected as one of the Top Ten Science and Technology News of Hunan Province in 2021), as well as the clinical pharmacology modeling and statistics cloud platform CPhaMAS, which is currently registered and used in 26 countries and regions worldwide. The team also places emphasis on consolidating and systematizing knowledge, serving as editors or contributing authors of multiple national-level planned textbooks and monographs, including Clinical Pharmacology and Pharmacometrics, thereby promoting the standardization of disciplinary education. To date, the team has published more than 200 SCI-indexed papers in high-impact international journals such as Clinical Pharmacology & Therapeutics, British Journal of Pharmacology, Briefings in Bioinformatics, Clinical Pharmacokinetics, The AAPS Journal, Pharmaceutical Research, CPT: Pharmacometrics & Systems Pharmacology, Antimicrobial Agents and Chemotherapy, International Journal of Antimicrobial Agents, and Journal of Antimicrobial Chemotherapy.

In the area of regulatory science and technical standards, multiple team members have participated in the development of more than 50 technical guidelines issued by the National Medical Products Administration (NMPA), including key documents such as the Technical Guidelines for Model-Informed Drug Development and the Technical Guidelines for Exposure–Response Relationship Studies. The team has also contributed to the development of two ICH guidelines, supported the revision of one FDA product-specific guidance, and participated in the formulation of the Chinese Pharmacological Society’s group standard, Standard Operating Procedures for Population Pharmacokinetic–Pharmacodynamic Analysis, thereby contributing to the standardization of quantitative pharmacology methodologies in China and their alignment with international practices.

Currently, the team focuses on the following major research directions in quantitative pharmacology:

1) Development of novel physiologically based pharmacokinetic modeling platforms for special routes of administration, including pulmonary inhalation and transdermal delivery;

2) Development of oral biopharmaceutics modeling platforms to optimize the prediction of oral drug absorption and formulation development;

3) Precision dosing research in special populations based on PopPK and PBPK models, including pediatrics, pregnant women, obese patients, and critically ill patients;

4) Development of quantitative systems pharmacology models, with a focus on diabetes, oncology, and drug-induced cardiotoxicity and other disease and safety domains;

5) Promotion of deep integration between artificial intelligence and traditional quantitative pharmacology models, and exploration of new paradigms combining data-driven and mechanism-driven approaches to enhance model robustness and predictive performance in small-sample, high-noise clinical scenarios;

6) Continuous optimization of the clinical pharmacology modeling and statistics cloud platform (CPhaMAS), with a focus on core functions in classical pharmacokinetics and population pharmacokinetics, and the exploration of AI-based automation in data preprocessing, model selection, and result interpretation to improve modeling efficiency and standardization.