创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

缓控释制剂仿制药的一致性研究重点和策略探讨

Key Points and Strategies for Consistency Study of Sustained- or Controlled-Release Generic Drugs

  • 摘要: 我国仿制药质量和疗效一致性评价是国务院于2012年1月开始、2015年8月全面开展的一项系统工程,但是延释仿制药推进速度尤为缓慢。借鉴国内外文献资料、结合实际工作经验,试从综合考虑与设计、参比制剂的选择、处方前研究、处方工艺研究、释放方法研究、中试放大等重点环节提出几点自身认识,以供参考。

     

    Abstract: The consistency evaluation of quality and efficacy of generic drugs in China is a systematic project that was first launched by the State Council in January 2012 and then extensively carried forward in August 2015. However, the propelling speed of extended-release generic drugs is particularly slow. Referring to domestic and foreign literatures and combing practical work experience, the author tries to put forward some personal opinions on some key links such as comprehensive consideration and design, selection of reference preparation, pre-formulation research, research on formulation technology, research on release method and pilot scale production, so as to provide reference for related researchers.

     

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