探索用于特考韦瑞马的扩大准入研究性新药方案：2022年纽约市猴痘疫情期间公私合营医院合作的经验教训
Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public-private hospital partnership during the 2022 NYC mpox outbreak.
作者信息
Mgbako Ofole, Chan Justin, Pitts Robert A, DiLorenzo Madeline A, Knutsen Dorothy, Mazo Dana
机构信息
Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA.
Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA.
出版信息
Antimicrob Steward Healthc Epidemiol. 2023 Jun 29;3(1):e110. doi: 10.1017/ash.2023.194. eCollection 2023.
During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND's regulatory requirements and rapidly provide tecovirimat to patients.
在2022年猴痘疫情期间，通过一项扩大准入研究性新药（EA-IND）方案获取了特考韦瑞马。我们利用纽约市一家独特的公私合营医院合作伙伴关系，创建了一个新颖的基础设施，以应对EA-IND的监管要求，并迅速为患者提供特考韦瑞马。
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