抗药物抗体检测验证：行业调查结果。
Antidrug antibody assay validation: industry survey results.
作者信息
Gorovits Boris
机构信息
Wyeth Research, 401 N Middletown Rd., Pearl River, New York 10965, USA.
出版信息
AAPS J. 2009 Mar;11(1):133-8. doi: 10.1208/s12248-009-9091-6. Epub 2009 Mar 3.
Abstract
Immunogenicity of biopharmaceutical products has attracted considerable attention from the industrial, academia, and regulatory organizations. Many methods exist to detect and characterize level of antidrug antibody response in patients. Still, additional work is required to harmonize various approaches used throughout the industry. This review presents results of a survey sponsored by the American Association of Pharmaceutical Scientists that was designed to collect relevant information and to understand various methods used throughout the bioanalytical field for the detection and evaluation of antidrug antibody responses.
摘要
生物制药产品的免疫原性已引起了工业界、学术界和监管机构的广泛关注。现有多种方法可用于检测和表征患者体内抗药物抗体反应的水平。然而，仍需开展更多工作以协调整个行业所使用的各种方法。本综述介绍了由美国药物科学家协会发起的一项调查结果，该调查旨在收集相关信息并了解生物分析领域用于检测和评估抗药物抗体反应的各种方法。
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