模型引导的药物研发技术在国内制药工业界的实践情况

李健, 王玉珠, 王骏 - 中国临床药理学与治疗学, 2024 - manu41.magtech.com.cn
2020 年, 国家药品监督管理局颁布了《 模型引导的药物研发技术指导原则》 等技术指南,
为建模与模拟技术在新药研发中的应用提供了技术指导. 2022 年7 月, 为了解国内新药研发企业 …

Practice of model-informed drug development in pharmaceutical industry in China

J LI, Y WANG, J WANG - Chinese Journal of Clinical …, 2024 - manu41.magtech.com.cn
Guideline of model-informed drug development was published by National Medical
Products Administration in 2020, which provided technical guidance for the application of …

Applications of model informed drug development (MIDD) in drug development lifecycle and regulatory review

A Mitra, Y Wang - Pharmaceutical Research, 2022 - Springer
Model-informed drug development (MIDD) is the application of a wide range of
mathematical, statistical, and biological models to facilitate drug development, decision …

Applications of model-informed drug development (MIDD) on new drug research and development

J LI - Chinese Journal of Clinical Pharmacology and …, 2020 - pesquisa.bvsalud.org
Model-informed drug development (MIDD) refers to the application of various mathematical
models in drug development, in order to facilitate the decision-making process. There have …

Model‐informed Drug Development (MIDD) Regarding Regulatory Requirements and Thinking

W Wang, Y Wang, D Ouyang - … ‐AI and Modeling in Pharma 4.0, 2024 - Wiley Online Library
Drug development is fraught with difficulties, and pharmaceutical technology is becoming
increasingly complex. With the development of computer technology, the pharmaceutical …

MIDD-An Investment for the Future

B Patel - 日本臨床薬理学会学術総会抄録集第44 回日本臨床薬理 …, 2023 - jstage.jst.go.jp
抄録 Over the last two decades, we have impacted decision making on numerous
frontsthrough the application of model-informed drug discovery and development (MIDD) …

[HTML][HTML] Model informed drug development: collaboration through a common framework

RJ Anziano, PA Milligan - Clinical Pharmacology and Therapeutics, 2021 - ncbi.nlm.nih.gov
Model-informed drug development (MIDD) utilizes the knowledge extracted from relevant
data to improve the efficiency of decision making within the pharmaceutical industry. The …

[HTML][HTML] Role of model-informed drug development approaches in the lifecycle of drug development and regulatory decision-making

R Madabushi, P Seo, L Zhao, M Tegenge… - Pharmaceutical …, 2022 - Springer
Abstract Model-informed drug development (MIDD) is a powerful approach to support drug
development and regulatory review. There is a rich history of MIDD applications at the US …

Model-informed drug development: steps toward harmonized guidance

S Marshall, M Ahamadi, J Chien… - Clinical …, 2023 - researchportal.unamur.be
Global alignment of expectations is required to achieve consistency in the planning,
conduct, reporting, and regulatory review of modelinformed drug development (MIDD) …

[引用][C] The US Food and Drug Administration's model‐informed drug development paired meeting pilot program: early experience and impact

R Madabushi, JM Benjamin, R Grewal… - Clinical …, 2019 - Wiley Online Library
Model-informed drug development (MIDD) is a powerful approach to increase efficiency in
drug development, impact regulatory outcomes, and improve drug benefit–risk balance. 1, 2 …