依托GLP实验室的《新药研究与评价》课程教学探索与实践

Exploration and Practice in the Teaching of the New Drug Research and Evaluation Course Relying on a GLP Laboratory

摘要: 新药研发是医学与药学教育中的核心环节，其中安全性与有效性评价尤为关键。然而，现行《新药研究与评价》课程仍存在理论与实践脱节、规范意识薄弱以及缺乏全过程训练等问题。依托GLP (Good Laboratory Practice)实验室，本研究在课程中引入质量管理体系与标准操作规程，将课堂教学、实验训练、虚拟仿真与结果评价有机结合，构建了一体化教学模式。教学实践结果表明，该模式能够有效提升学生的操作规范性和数据完整性，显著增强实验技能与科研合规意识，并促进其对新药研发全过程的系统理解。该探索为课程改革提供了新思路，也为药学与医学人才培养模式的优化提供了可推广的经验。

Abstract: New drug research and development is a core component of medical and pharmaceutical education, wherein the evaluation of safety and efficacy is particularly critical. However, the current “New Drug Research and Evaluation” course still faces issues such as the disconnection between theory and practice, weak normative awareness, and a lack of comprehensive training covering the entire process. By leveraging a Good Laboratory Practice (GLP) facility, this study introduced a quality management system and standard operating procedures (SOPs) into the curriculum. It organically integrated classroom teaching, experimental training, virtual simulation, and result evaluation to construct a holistic teaching model. The results of teaching practice demonstrate that this model can effectively enhance students’ operational standardization and data integrity, significantly improve their experimental skills and awareness of scientific research compliance, and promote a systematic understanding of the entire new drug R&D process. This exploration provides new insights for curriculum reform and offers transferable experience for optimizing the training model of pharmaceutical and medical professionals.