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Updated: Jun 3, 2025

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
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欧洲药物局加速评估的执行情况

Vittorio Del Grosso1, Martina Perini1, Giorgio Casilli2

  • 1Department of Pharmaceutical Sciences, Università del Piemonte Orientale "Amedeo Avogadro", Novara, Italy.

British journal of clinical pharmacology
|January 10, 2025
PubMed
概括

少数药物使用欧洲药物局 (EMA) 的加速评估 (AA) 途径. 虽然这些药物在卫生技术评估 (HTA) 机构的审查速度更快,但它们并不总是显示出显著的治疗价值.

关键词:
意大利药品管理局 (AIFA)联合联邦委员会 (G-BA)欧洲药品管理局 欧洲药品管理局高级卫生当局 (HAS)快速评估是指加速评估的方法.药物监管 药物监管 药物监管

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