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Updated: Jan 16, 2026

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探索复杂药物的仿制版本所面临的挑战:一个范围审查

Amatha Sreedevi1, Elstin Anbu Raj2, D Sreedhar1

  • 1Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India.

Systematic reviews
|September 30, 2025
PubMed
概括

本次审查确定了开发复杂仿制药的关键挑战和战略,包括活性药物成分 (API) 和新药输送系统. 它强调需要先进的分析和监管协调,以改善获得高质量的复杂仿制药的机会.

关键词:
复杂的仿制药是复杂的.关键的质量属性是关键的质量属性.障碍物 障碍物 障碍物混合药物 混合药物是一种混合药物.质量和安全 质量和安全

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