在监管决策中加速采用新方法：一个行业观点

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, Eddie Reilly, Michelle Rohrer, Katrin Rupalla, Jacintha Shenton, Jerry Stewart, Mark Taisey, Raymond C. Votzmeyer, Matthew P. Wagoner, Max Wegner, Kathy Williams

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引用次数: 0

摘要

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

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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Nature Reviews Drug Discovery

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