| 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。 |
| 关键词: 兽药产品批准文号 比对试验 药学研究 问题 |
| DOI： |
| 投稿时间：2024-02-26修订日期：2024-04-12 |
| 基金项目: |
|
| The Common Problems Analysis on pharmaceutical study dossier of Veterinary Drug Registration (application of chemical Veterinary Drug ) |
|
| (China institute of veterinary drug control) |
| 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.. |
| Key words: Veterinary Drug Registration Comparison test Pharmaceutical research Problems |
