Accelerating the speed of innovative anti-tumor drugs to first-in-human trials incorporating key de-risk strategies

Accelerating the speed of innovative anti-tumor drugs to first-in-human trials incorporating key de-risk strategies

Pharmaceutical companies have recently focused on accelerating the timeline for initiating first-in-human (FIH) trials to allow quick assessment of biologic drugs. For example, a stable cell pool can be used to produce materials for the toxicology (Tox) study, reducing time to the clinic by 4–5 mont...

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Bibliographic Details
Main Authors: Yuqi Wang, Quan Quan, Camille Gleason, Helin Yu, Lujia Peng, Yanshen Kang, Ling Jiang, Kailun Wu, Jie Pan, Moxiyele Bao, Qing Zhu, Meiqi Yi, Ming Fang, Yue Zheng, Ling Qiu, Bin Xu, Xiang Li, Jinfeng Song, Jiamu Sun, Zheng Zhang, Zijun Su, Jara Lin, Yuanyuan Xie, April Xu, Xiling Song, Chichi Huang, Zhirong Shen, Lai Wang, Jing Song
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Series:mAbs
Subjects:
Acceleration
characterization
CMC
first-in-human
monoclonal antibody
risk mitigation
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2023.2292305
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