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
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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。
Citation Impact
2024 CiteScore: | 11.7 |
2024 Journal Impact Factor : | 5.5 |
Submission to the First Decision | 11 days |
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