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Advances and applications of quantitative systems pharmacology modeling and virtual clinical trials in modern drug development
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Chen ZHAO1, 2, *, Gai-ling LI3, Ya-ning WANG4
Acta Pharmaceutica Sinica | 2023, 58(11) : 3296 - 3310
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Acta Pharmaceutica Sinica | 2023, 58(11): 3296-3310
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Advances and applications of quantitative systems pharmacology modeling and virtual clinical trials in modern drug development
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Chen ZHAO1, 2, *, Gai-ling LI3, Ya-ning WANG4
Affiliations
  • 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
Published: 2023-11-12 doi: 10.16438/j.0513-4870.2023-0329
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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.

quantitative systems pharmacology  /  virtual clinical trial  /  mechanistic modeling and simulation  /  model-informed drug development  /  translational medicine
Chen ZHAO, Gai-ling LI, Ya-ning WANG. Advances and applications of quantitative systems pharmacology modeling and virtual clinical trials in modern drug development[J]. Acta Pharmaceutica Sinica, 2023 , 58 (11) : 3296 -3310 . DOI: 10.16438/j.0513-4870.2023-0329
Year 2023 volume 58 Issue 11
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doi: 10.16438/j.0513-4870.2023-0329
  • Receive Date:2023-03-18
  • Online Date:2025-11-21
  • Published:2023-11-12
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  • Received:2023-03-18
  • Revised:2023-05-12
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Affiliations
    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
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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