新方法方法论：临床药理学家应该准备什么。

IF 5.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacology & Therapeutics Pub Date : 2025-08-24 DOI:10.1002/cpt.70046

Yanguang Cao, William Polacheck

引用次数: 0

摘要

随着新方法方法学（NAMs）在新药研究（IND）应用中获得监管动力，临床药理学家在这些方法学的开发、量化和实施方面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动物使用以支持早期药物开发至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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New Approach Methodologies: What Clinical Pharmacologists Should Prepare For.

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.

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来源期刊

Clinical Pharmacology & Therapeutics 医学-药学

CiteScore

12.70

自引率

7.50%

发文量

290

审稿时长

2 months

期刊介绍： Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.