广告
药品
药物开发
药代动力学
药理学
分布(数学)
制药工业
抗体-药物偶联物
结合
单克隆抗体
计算生物学
医学
化学
生物利用度
抗体
生物
免疫学
数学
数学分析
作者
Eugenia Kraynov,Ajith V. Kamath,Markus Walles,Edit Tarcsa,Antoine Deslandes,Ramaswamy A. Iyer,Amita Datta‐Mannan,Priya Sriraman,Michaela Bairlein,Johnny Yang,Michael E. Barfield,Guangqing Xiao,Enrique Escandón,W. Wang,Dan A. Rock,Nagendra Chemuturi,David J. Moore
标识
DOI:10.1124/dmd.115.068049
摘要
An antibody-drug conjugate (ADC) is a unique therapeutic modality composed of a highly potent drug molecule conjugated to a monoclonal antibody. As the number of ADCs in various stages of nonclinical and clinical development has been increasing, pharmaceutical companies have been exploring diverse approaches to understanding the disposition of ADCs. To identify the key absorption, distribution, metabolism, and excretion (ADME) issues worth examining when developing an ADC and to find optimal scientifically based approaches to evaluate ADC ADME, the International Consortium for Innovation and Quality in Pharmaceutical Development launched an ADC ADME working group in early 2014. This white paper contains observations from the working group and provides an initial framework on issues and approaches to consider when evaluating the ADME of ADCs.
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