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推进先进疗法药品的潜能测试开发:全面的方法和监管见解

Alaa Abdellatif1, Melissa Bou Jaoudeh1, Alex Zwiers1,2

  • 1ProductLife Group, Courbevoie, France.

Human gene therapy
|April 21, 2025
PubMed
概括

为先进治疗药物 (ATMP) 开发可靠的功效测试需要产品特定的策略. 这项研究提出了一个框架,并强调了可靠的ATMP功效测试的新技术,与监管需求保持一致.

关键词:
欧洲药物管理局指南美国食品和药物管理局的指导方针先进疗法的药物,先进疗法的药物.细胞和基因疗法细胞和基因疗法.强度测试试验 强度测试试验监管挑战 监管挑战 监管挑战

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