兽药产品批准文号药学研究资料常见问题浅析  

The Common Problems Analysis on Pharmaceutical Study Dossier of Veterinary Drug Registration

作　　者：宫爱艳[1] 郝智慧[2] 冯克清[1] 安洪泽[1] GONG Ai-yan;HAO Zhi-hui;FENG Ke-qing;AN Hong-ze(China Institute of Veterinary Drug Control,Beijing 100081,China;College of Veterinary Medicine,China Agricultural University,Beijing 100094,China)

机构地区：[1]中国兽医药品监察所(农业农村部兽药评审中心),北京100081 [2]中国农业大学动物医学院,北京100094

出　　处：《中国兽药杂志》2024年第7期20-25,共6页Chinese Journal of Veterinary Drug

摘　　要：本文通过对已审药学资料的审查分析,从产品信息、处方、工艺、质量标准、稳定性研究等方面对药学申报资料的常见问题加以分析总结并提出了针对性建议,旨在规范药学研究资料编写,以期对兽药产品批准文号申请有所帮助。Through cheek and analysis on 1100 applications for pharmaceutical research data on common problems and status on these applications are discussed in aspects administrative in formation,pharmaceutical formulation and process research,quality research,stability research sections,and puts forward some suggestions to standardize the preparation of pharmaceutical research data with a view to the application for registration of enterprises to help..

关 键 词：兽药产品批准文号 比对试验 药学研究 问题 

分 类 号：S859.79[农业科学—临床兽医学]