相关实验视频

Updated: Jan 13, 2026

Early Viral Entry Assays for the Identification and Evaluation of Antiviral Compounds

Early Viral Entry Assays for the Identification and Evaluation of Antiviral Compounds

Published on: October 29, 2015

作为抗病毒药物的生物类药物:科学和监管准备就在传染性威胁中快速,经济高效地部署

Ahmad Z Al Meslamani¹, Anan S Jarab², Eman Merghani Ali Mohammed³

¹College of Pharmacy, Al Ain University, Abu Dhabi, United Arab Emirates.

Expert opinion on biological therapy

|January 7, 2026

概括

生物类似抗病毒药物可以通过实现多制造商准备来改善疫情应对. 利用监管和制造平台可以简化这些关键药物的获取.

科学领域:

生物制品和生物类似药物
开发抗病毒药物的开发.
监管科学是一种监管科学.

背景情况:

目前的抗病毒生物药物获取受到制造和试验时间表的限制.
生物类似开发为多制造商为疫情做好准备提供了一条途径.

研究的目的:

审查证据和战略,以利用生物类似平台的抗病毒生物药物.
探索减少对长期临床疗效研究的依赖的途径.

主要方法:

对抗病毒生物制剂,分析和制造的证据进行系统审查.
监管趋同和卫生技术评估的评估.
药理动力学/药理动力学 (PK/PD) 生物标志物的分析和分析相似性.

主要成果:

基于PK/PD的分析第一途径可以减少III期试验的要求.
平台化学,制造和控制 (CMC) 和技术转让是关键的推动因素.
建模和成本效益分析的整合解决了股权问题.

结论:

生物类似抗病毒药物可以提高全球对病毒爆发的准备.
分析第一的方法和监管协调对于快速发展至关重要.
紧急使用的运行需要预先定义的包裹和协议.

关键词:

分析性可比性分析性可比性药理动力学/药理动力学生物标志物适应性卫生技术评估适应性卫生技术评估生物类似药的生物类似药.单次使用的模块化生物制造.

更多相关视频

High-throughput Screening for Broad-spectrum Chemical Inhibitors of RNA Viruses

High-throughput Screening for Broad-spectrum Chemical Inhibitors of RNA Viruses

Published on: May 5, 2014

Assays for the Identification of Novel Antivirals against Bluetongue Virus

Assays for the Identification of Novel Antivirals against Bluetongue Virus

Published on: October 11, 2013

相关概念视频

Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...