Cao Yanguang, Polacheck William
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.
Clin Pharmacol Ther. 2025 Aug 24. doi: 10.1002/cpt.70046.
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.
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。