AI Article Synopsis
- Biopharmaceutical research in China has seen significant growth over the last decade due to supportive government policies and increased investments in life sciences.
- Model-informed drug development (MIDD) is shifting from academic research to a key aspect of drug discovery and development in China, with the regulatory agency playing a crucial role.
- The article discusses the current state of MIDD, its challenges and opportunities, and compares China's approach with other regions that have more established practices, emphasizing its potential to improve drug development processes.
Article Abstract
In the past decade, biopharmaceutical research and development in China has been notably boosted by government policies, regulatory initiatives and increasing investments in life sciences. With regulatory agency acting as a strong driver, model-informed drug development (MIDD) is transitioning rapidly from an academic pursuit to a critical component of innovative drug discovery and development within the country. In this article, we provided a cross-sectional summary on the current status of MIDD implementations across early and late-stage drug development in China, illustrated by case examples. We also shared insights into regulatory policy development and decision-making. Various modeling and simulation approaches were presented across a range of applications. Furthermore, the challenges and opportunities of MIDD in China were discussed and compared with other regions where these practices have a more established history. Through this analysis, we highlighted the potential of MIDD to enhance drug development efficiency and effectiveness in China's evolving pharmaceutical landscape.
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| http://dx.doi.org/10.1016/j.addr.2024.115459 | DOI Listing |
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