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
宫爱艳 1郝智慧 2冯克清 1安洪泽1
作者信息
- 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
- 折叠
摘要
本文通过对兽药比对试验目录产品批准文号申请资料中药学资料的审查,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分析总结并提出对策建议,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.
Abstract
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Key words
veterinary drug registration/comparison test/pharmaceutical research/problems引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据