Advances and applications of quantitative systems pharmacology modeling and virtual clinical trials in modern drug development
10.16438/j.0513-4870.2023-0329
- VernacularTitle:新药研发中的定量系统药理学 (QSP) 模型与虚拟临床试验: 发展及前沿应用
- Author:
Chen ZHAO
1
,
2
;
Gai-ling LI
3
;
Ya-ning WANG
4
Author Information
1. School of Pharmacy, Nanjing Medical University, Nanjing 210000, China
2. First Affiliated Hospital of Nanjing Medical University, Nanjing 210000, China
3. Certara Inc, Shanghai 200000, China
4. Createrna Science and Technology, Wuhan 430000, China
- Publication Type:Research Article
- Keywords:
quantitative systems pharmacology;
virtual clinical trial;
mechanistic modeling and simulation;
model-informed drug development;
translational medicine
- From:
Acta Pharmaceutica Sinica
2023;58(11):3296-3310
- CountryChina
- Language:Chinese
-
Abstract:
Quantitative systems pharmacology (QSP) modeling is an emerging computational medicine approach with growing applications and significance in modern drug development. QSP models are generally formulated based on multiscale disease mechanisms and drug-target interactions, which makes them capable of integrating multimodal data from the preclinical and clinical space. This also enables them to generate quantitative characterization of the dynamic disease progression as well as high-throughput predictions of drug-induced efficacy and toxicity signals. Therefore, QSP modeling and model-based virtual clinical trials have been widely implemented to guide drug development, in scenarios such as target identification and assessment, clinical trial design, evaluation of combination therapy and biomarkers, and personalized medicine. In US and Europe, QSP modeling has been developing rapidly in the past 10 years and is now an integral part of the model-informed drug development paradigm; however, in China it is still a nascent field. Here we will present a comprehensive review of the recent advancements of QSP and its impact in modern drug development through a number of case studies. This review will provide guidance for the future drug development efforts and the growth of QSP practice in China.
