指导原则解读系列专题_十七_药学研究资料综述撰写的基本考虑_一_.pdfVIP

Chinese Journal ofN ew Drugs 2010, 19( 4) # # n () () , ( 国家食品药品监督管理局药品审评中心, 北京 100038) [] 药学研究是药物研发的重要组成部分, 是药物进行 全性有效性研究的基础药学研究资 料综述应体现申报品种整个药学研究工作的总结分析和自我评价内容, 它对于注册申请人以及技术审评人 员全面系统地了解申报品种的药学研究内容具有非常重要的意义文中根据相关技术指导原则, 对药学研 究综述资料的撰写内容以及需关注的相关技术问题进行了阐述, 供药品注册和药学研究工作参考, 以提高注 册质量和效率 [] 药学研究; 综述资料; 撰写规范 [] R95 [] C [] 1003 3734( 2010) 04 0277 04 General con sideration on organ ization of summ ary in pharm aceutical research YU Hong, ZHANG Yu hu (Centerf orD rug Evaluation, StateFood and Drug Administration, Beij ing 100038, China) [ Abstract] Pharmaceutical research is a basis for safety and efficacy studies in development process of phar maceutical products1 The summ ary of pharmaceutical research data should present an overall profile, including a nalysis and evaluation of results in each part of chem ical development studies1 The contents should provide compre hensive understanding of the product and itsmanufacturing process for applicants and reviewers1 Based on the rele vant guidelines, this article describes the suggested contents and key consideration for applicants and researcher, which w ill help to mi prove quality and efficiency of drug registration1 [K ey w ords] pharm aceutical research; summ ary; specification , , , , 1 5 ) ) ) 6 2006, , , , , ; , , ,