临床药理学支持单克隆抗体药物开发

IF 0.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL AIMS Medical Science Pub Date : 2022-01-01 DOI:10.3934/medsci.2022014
Sharon Lu
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引用次数: 0

摘要

临床药理学是一门多学科交叉的学科,在单克隆抗体的发展中起着至关重要的作用。除了了解药理学、药代动力学、模型模拟、生物统计学和免疫原性的要求外,明智地实施策略和策略以满足各机构根据指导文件的要求也是至关重要的。本文综述了临床药理学研究的必要性、目标依赖性、发展策略依赖性和非通常需要性。回顾了最近在临床药理学方面的进展,如QSP的应用与人工智能和机器学习技术的整合。
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Clinical pharmacology to support monoclonal antibody drug development
Clinical pharmacology is a multidisciplinary function playing a critical role in the monoclonal antibody development. Besides the requirements of understanding pharmacology, pharmacokinetics, model simulation, biostatistics and immunogenicity, wisely implementation of tactics and strategies to fulfill the agencies' requirements per guidance documents are critical. In this review, clinical pharmacology studies categorized as required, target dependent, development strategy dependent, and not usually needed are discussed. The review ends with the outlook of recent initiations in the clinical pharmacology such as the application of QSP with the integration of AI and machine learning technologies.
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来源期刊
AIMS Medical Science
AIMS Medical Science MEDICINE, RESEARCH & EXPERIMENTAL-
自引率
14.30%
发文量
20
审稿时长
12 weeks
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