【摘要】 药学研究是中药新药研发的重要组成部分,是进行药物安全性、有效性研究和评价的基础。药学研究综述资料是《药品注册管理办法》(局令28号)中药新药注册申请要求申报的第7号资料,是对药学研究工作的总结、分析与评价,对于申请人和审评者全面了解药学研究情况具有重要的意义。所以撰写好药学综述资料显得非常重要。结合审评体会,从品种概况、处方及辅料、生产工艺、质量研究与质量标准、检验报告、稳定性考察、说明书包装标签以及分析与评价等方面对如何撰写药学综述资料进行了阐述,仅供申请生产注册时参考,以提高注册申请的质量和效率。更多还原

【Abstract】 Summary of pharmaceutical research data of traditional Chinese medicine should present an overall profile of studies,analysis and self-evaluation,playing an important role for those applicants and reviewers who have a profound understanding of product and its manufacturing process. As booming acknowledge of new drug studies,based on these related guidelines and evaluation experience of authors,this paper gives suggestions contents and main consideration about summary of pharmaceutical research of new drug application for researcher and reviewers,including varieties profiles,prescriptions and accessories,production process,quality research and standards,inspection reports,stability test,instructions,packaging,labeling,analysis and evaluation,which will help to improve quality and efficiency of drug registration.更多还原