Accelerating adoption of new approach methodologies in regulatory decision making: an industry perspective

IF 101.8 1区医学 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Nature Reviews. Drug Discovery Pub Date : 2025-03-06 DOI:10.1038/d41573-025-00038-6

Andrew S. Robertson, Nahid Latif, Imein Bousnina, Donna Boyce, Kevin Carl, Sean P. Curtis, Jennifer Dudinak, Carlos O. Garner, Michael Garvin, Sabine Luik, Koen Nauwelaerts, Eddie Reilly, Michelle Rohrer, Katrin Rupalla, Jacintha Shenton, Jerry Stewart, Mark Taisey, Axel Vicart, Raymond C. Votzmeyer, Matthew P. Wagoner, Max Wegner, Kathy Williams

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Abstract

Clear and harmonized regulatory guidelines are needed to realize the potential of new approach methodologies for improving the predictivity of nonclinical drug candidate assessment. Clear and harmonized regulatory guidelines are needed to realize the potential of new approach methodologies for improving the predictivity of nonclinical drug candidate assessment.

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在监管决策中加速采用新方法：一个行业观点

需要明确和协调的监管指南来实现新方法方法的潜力，以提高非临床候选药物评估的预测性。

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Nature Reviews. Drug Discovery 医学-生物工程与应用微生物

CiteScore

137.40

自引率

0.30%

发文量

227

期刊介绍： Nature Reviews Drug Discovery is a monthly journal aimed at everyone working in the drug discovery and development arena. Each issue includes: Highest-quality reviews and perspectives covering a broad scope. News stories investigating the hottest topics in drug discovery. Timely summaries of key primary research papers. Concise updates on the latest advances in areas such as new drug approvals, patent law, and emerging industry trends and strategies.

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