关于ICH M13A生物等价性指南的公开论坛会议
Henning Blume1, Steven Wedemeyer2, Anne Seidlitz3
1Frankfurt Foundation Quality of Medicines, Frankfurt am Main, Germany.
概括
欧洲制药科学联合会 (EUFEPS) 讨论了ICH M13A关于立即释放口服剂型生物等价性指南草案. 关键点包括研究群体,食物影响和药物产品的变化,建议修订指南.
科学领域:
- 制药科学 制药科学
- 生物制药生物制药公司
- 药物开发 药物开发
背景情况:
- 欧洲制药科学联合会 (EUFEPS) 生物可用性和生物制药网络召开了一个公开讨论论坛.
- 论坛的重点是国际协调理事会 (ICH) M13A关于立即释放的固体口服剂型的生物等价性指南草案.
- 该活动由制药过程技术协会 (APV) 和法兰克福药品质量基金会共同赞助.
研究的目的:
- 总结和强调EUFEPS公开讨论论坛关于ICH M13A指导方针草案的主要讨论点.
- 提出关于修订"生物等效指南"草案中概述的具体要求的论点.
- 促进学术界和行业科学家以及ICH起草小组的欧洲成员之间的对话.
主要方法:
- 一个公开讨论论坛于2023年5月15日在德国法兰克福组织.
- 来自学术界和工业界的科学家参加了研讨会.
- 讨论的重点是ICH M13A指南草案中的拟议法规.
主要成果:
- 讨论了指导方针草案的关键方面,包括研究群体的选择 (男性/女性).
- 讨论讨论了禁食与食生物等价性研究的必要性以及药物产品含量变化的影响.
- 处理异常血形状的方法和对依赖pH的可溶性药物的特定要求也是关键话题.
结论:
- 该论坛产生了重要的论点,支持修订ICH M13A指南草案中的某些要求.
- 讨论强调了对生物等价性研究设计参数进行彻底审查的必要性.
- 科学专家和监管机构之间的合作对于完善制药指南至关重要.
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