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新方法学:临床药理学家应做好哪些准备。

New Approach Methodologies: What Clinical Pharmacologists Should Prepare For.

作者信息

Cao Yanguang, Polacheck William

机构信息

Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Lampe Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Chapel Hill, North Carolina, USA.

出版信息

Clin Pharmacol Ther. 2025 Aug 24. doi: 10.1002/cpt.70046.

DOI:10.1002/cpt.70046
PMID:40849915
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12404678/
Abstract

As new approach methodologies (NAMs) gain regulatory momentum for Investigational new drug (IND) applications, clinical pharmacologists are uniquely positioned to collaborate with preclinical and translational teams in the development, quantification, and implementation of these methodologies. Their involvement is critical to ensuring a reduction in animal use to support early-phase drug development.

摘要

随着新方法学(NAMs)在研究性新药(IND)申请中获得监管方面的推动,临床药理学家在这些方法学的开发、量化和实施过程中,与临床前和转化团队合作具有独特的优势。他们的参与对于确保减少支持早期药物开发所需的动物使用量至关重要。

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本文引用的文献

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Application of new approach methodologies for nonclinical safety assessment of drug candidates.新方法学在候选药物非临床安全性评估中的应用。
Nat Rev Drug Discov. 2025 May 2. doi: 10.1038/s41573-025-01182-9.
2
Understanding the Lymphatic System: Tissue-on-Chip Modeling.了解淋巴系统:芯片上组织建模。
Annu Rev Biomed Eng. 2025 May;27(1):73-100. doi: 10.1146/annurev-bioeng-110222-100246. Epub 2025 Jan 22.
3
Optimizing Clinical Translation of Bispecific T-cell Engagers through Context Unification with a Quantitative Systems Pharmacology Model.通过与定量系统药理学模型的上下文统一来优化双特异性 T 细胞衔接器的临床转化。
Clin Pharmacol Ther. 2024 Aug;116(2):415-425. doi: 10.1002/cpt.3302. Epub 2024 May 15.
4
Challenges and gaps in immunosafety evaluation of therapeutics: An IQ DruSafe survey.治疗药物免疫原性安全性评价的挑战和差距:IQ DruSafe 调查。
Regul Toxicol Pharmacol. 2024 Jun;150:105630. doi: 10.1016/j.yrtph.2024.105630. Epub 2024 Apr 18.
5
The application of organ-on-chip models for the prediction of human pharmacokinetic profiles during drug development.器官芯片模型在药物开发过程中预测人体药代动力学特征的应用。
Pharmacol Res. 2023 Sep;195:106853. doi: 10.1016/j.phrs.2023.106853. Epub 2023 Jul 18.
6
Human organs-on-chips for disease modelling, drug development and personalized medicine.用于疾病建模、药物开发和个性化医疗的人体器官芯片。
Nat Rev Genet. 2022 Aug;23(8):467-491. doi: 10.1038/s41576-022-00466-9. Epub 2022 Mar 25.
7
Phase 0/microdosing approaches: time for mainstream application in drug development?零期/微剂量研究方法:是否到了在药物研发中主流应用的时机?
Nat Rev Drug Discov. 2020 Nov;19(11):801-818. doi: 10.1038/s41573-020-0080-x. Epub 2020 Sep 8.
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Early-drug development in the era of immuno-oncology: are we ready to face the challenges?免疫肿瘤学时代的早期药物研发:我们准备好迎接挑战了吗?
Ann Oncol. 2019 Oct 1;30(10):1670. doi: 10.1093/annonc/mdz211.