Model Informed Drug Development and Regulation in China: Challenges and Opportunities.
作者信息
Li Li, Han Hongcan, Wang Jun, Wei Chunmin, Wang Yuzhu, Li Min, Zhou Yu, Yang Jinbo
机构信息
Office of Biostatistics and Clinical Pharmacology, Center for Drug Evaluation, National Medical Products Administration, Beijing, China.
出版信息
CPT Pharmacometrics Syst Pharmacol. 2019 Feb;8(2):59-61. doi: 10.1002/psp4.12368. Epub 2019 Jan 4.
Abstract
摘要
相似文献
1
Model Informed Drug Development and Regulation in China: Challenges and Opportunities.
CPT Pharmacometrics Syst Pharmacol. 2019 Feb;8(2):59-61. doi: 10.1002/psp4.12368. Epub 2019 Jan 4.
2
Recent Advances in Drug Development and Regulatory Science in China.
Ther Innov Regul Sci. 2018 Nov;52(6):739-750. doi: 10.1177/2168479018764661. Epub 2018 Apr 3.
3
Non-Procrustean pathways for complex generic drugs development.
Ther Deliv. 2018 Sep;9(9):605-607. doi: 10.4155/tde-2018-0047.
4
Generating Model Integrated Evidence for Generic Drug Development and Assessment.
Clin Pharmacol Ther. 2019 Feb;105(2):338-349. doi: 10.1002/cpt.1282. Epub 2019 Jan 20.
5
Are Regulators Talking to Each Other Across Borders?
Clin Pharmacol Ther. 2020 Mar;107(3):481-483. doi: 10.1002/cpt.1761.
6
Iberoamerican Pharmacometrics Network Congress 2018 Report: Fostering Modeling and Simulation Approaches for Drug Development and Regulatory and Clinical Applications in Latin America.
CPT Pharmacometrics Syst Pharmacol. 2019 Apr;8(4):197-200. doi: 10.1002/psp4.12387. Epub 2019 Feb 22.
7
Defining orphan conditions in the context of the European orphan regulation: challenges and evolution.
Nat Rev Drug Discov. 2019 Jul;18(7):479-480. doi: 10.1038/nrd.2018.128.
8
Applications of Adaptive Designs in Generic Drug Development.
Clin Pharmacol Ther. 2021 Jul;110(1):32-35. doi: 10.1002/cpt.2050. Epub 2020 Oct 14.
9
Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.
AAPS J. 2024 Apr 24;26(3):55. doi: 10.1208/s12248-024-00924-8.
10
Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines.
Drug Discov Today. 2021 Oct;26(10):2221-2225. doi: 10.1016/j.drudis.2021.04.005. Epub 2021 Apr 20.
引用本文的文献
1
The effect of overuse by primary healthcare institutions on medical expenses: an empirical study from the western regions of China.
Front Public Health. 2025 May 9;13:1588806. doi: 10.3389/fpubh.2025.1588806. eCollection 2025.
2
PBPK Modeling: Empowering Drug Development and Precision Dosing in China.
CPT Pharmacometrics Syst Pharmacol. 2025 May;14(5):828-839. doi: 10.1002/psp4.70004. Epub 2025 Feb 18.
3
Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region.
Saudi Pharm J. 2024 Dec;32(12):102207. doi: 10.1016/j.jsps.2024.102207. Epub 2024 Nov 27.
4
Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment.
Int J Ophthalmol. 2024 Jan 18;17(1):157-163. doi: 10.18240/ijo.2024.01.21. eCollection 2024.
5
Revisiting Supersaturation of a Biopharmaceutical Classification System IIB Drug: Evaluation via a Multi-Cup Dissolution Approach and Molecular Dynamic Simulation.
Molecules. 2023 Oct 7;28(19):6962. doi: 10.3390/molecules28196962.
6
Editorial: Model-informed drug development and evidence-based translational pharmacology.
Front Pharmacol. 2022 Dec 12;13:1086551. doi: 10.3389/fphar.2022.1086551. eCollection 2022.
7
Modeling the disruption of respiratory disease clinical trials by non-pharmaceutical COVID-19 interventions.
Nat Commun. 2022 Apr 13;13(1):1980. doi: 10.1038/s41467-022-29534-8.
8
In Vitro to In Vivo Extrapolation Linked to Physiologically Based Pharmacokinetic Models for Assessing the Brain Drug Disposition.
AAPS J. 2022 Jan 13;24(1):28. doi: 10.1208/s12248-021-00675-w.
9
Regulatory utility of pharmacometrics in the development and evaluation of antimicrobial agents and its recent progress in China.
CPT Pharmacometrics Syst Pharmacol. 2021 Dec;10(12):1466-1478. doi: 10.1002/psp4.12716. Epub 2021 Oct 15.
10
Opening a debate on open-source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate.
CPT Pharmacometrics Syst Pharmacol. 2021 May;10(5):420-427. doi: 10.1002/psp4.12615. Epub 2021 May 1.
本文引用的文献
1
Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective.
CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):413-415. doi: 10.1002/psp4.12203. Epub 2017 Jun 1.
2
Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.
CPT Pharmacometrics Syst Pharmacol. 2016 Mar;5(3):93-122. doi: 10.1002/psp4.12049. Epub 2016 Mar 14.
3
The utility of modeling and simulation in drug development and regulatory review.
J Pharm Sci. 2013 Sep;102(9):2912-23. doi: 10.1002/jps.23570. Epub 2013 May 24.
4
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Clin Pharmacokinet. 2011 Oct;50(10):627-35. doi: 10.2165/11593210-000000000-00000.
5
Pharmacometrics for regulatory decision making: status and perspective.
Clin Pharmacokinet. 2011 Oct;50(10):625-6. doi: 10.2165/11594340-000000000-00000.
Zotero 插件