征稿特刊

新方法方法论（NAMs）的进展：从工作台开发和验证到监管采用

Advances in New Approach Methodologies (NAMs): From Bench Development and Validation to Regulatory Adoption

特刊简介：

本专题聚焦新方法学（NAMs）的三项核心内容：一是开发可减少、优化及替代药物研发中动物实验的 NAMs；二是展示其在药代动力学、药效学及毒性预测方面的临床转化成果；三是呈现 FDA、EMA 等监管机构对 NAMs 数据用于安全性评估和新药申报的观点。鉴于临床前模型向临床转化存在脱节，尤其是大分子药物领域，NAMs 作为具生理相关性的方法，其研发、验证与整合愈发受重视。本专题将探索革新药物安评与效价评估的前沿进展，推动 NAMs 融入药物研发与监管决策体系。

本期特刊议题包括但不限于：

• Microphysiological systems, organ-on-chip technologies and other physiologically-relevant systems for ADME, and toxicity predictions

• Computational NAMs: PBPK and QSP modeling, QSAR, in silico toxicology frameworks, AI/ML-integrated NAMs modeling platforms

• Non-mammalian models (Danio rerio, Drosophila and C. elegans) as alternatives to traditional animal studies

• Integration of multi-omics approaches to enhance mechanistic NAMs-based predictions

• Standardization, qualification and validation of NAMs

• Case studies demonstrating reduced reliability on preclinical studies in regulatory submissions

• Regulatory perspectives, including evaluation pathways, data expectations, and global harmonization for adoption of NAMs

• Role of clinical pharmacologists in advancing, qualifying, and integrating NAMs into drug development

• Limitations and future directions of integrating NAMs in clinical pharmacology and therapeutics

本期特刊截稿日期：

May 15, 2026

复制链接查阅特刊更多信息：

https://www.ascpt.org/Resources/ASCPT-News/View/ArticleId/28742/CPT-Call-for-Papers-New-Approach-Methodologies

期刊简介

Clinical Pharmacology & Therapeutics (CPT）是美国临床药理学与治疗学学会（ASCPT）的旗舰期刊，是实验和临床医学领域的权威跨学科期刊，致力于发表治疗学的性质、作用、疗效和评估方面的进展。

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