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Updated: May 24, 2025

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优化生物类似药的开发:现有方法来证明药物动力学和分析相似性,并提出单一参考方法的建议

Peter Kiely1, David Murray1

  • 1Parexel Consulting (PC), Regulatory Strategy, Regulatory Consulting, Parexel International, Dublin, Ireland.

Expert opinion on biological therapy
|March 4, 2025
PubMed
概括

生物类似药在美国和欧盟的批准存在监管障碍. 重复的药理动力学生物等价性研究往往是不必要的,突出了当前生物类似药开发过程中的低效性.

关键词:
这就是Adalimumab.这是bevacizumab的治疗方法.生物类似药物生物类似药物菲尔格拉斯蒂姆可以使用.佩格菲尔格拉斯蒂姆 (Pegfilgrastim) 是一家在美国的公司.参考产品 - - 参考产品这就是Rituximab.这就是特拉斯图祖马布 (trastuzumab).

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