【摘要】 新药研发中使用模型化评价方法,也即定量药理学方法,已得到相关监管机构的认可和支持。早在2004年美国食品药品监督管理局(FDA)发布的《新医药产品关键路径的机遇与挑战》白皮书中,就已将基于模型的药物研发(MBDD)理念作为提高药物研发水平的机遇之一,国家食品药品监督管理总局(CFDA)也有指导原则推荐使用MBDD方法。规范的文档编制,可以保证MBDD结果的质量和高效的审评,但目前国内尚无MBDD文档编制的规范。本文结合欧洲制药工业协会联盟(EFPIA)发布的模型介导的药物研发(MID3)白皮书和FDA、欧洲药品管理局(EMA)的指南,对MBDD规范的文档编制提出合理建议,为业界MBDD文档的撰写提供参考。更多还原

【Abstract】 Pharmacometrics is a useful tool,and its application in drug discovery and development has been approved and supported by relevant regulatory agencies. In 2004,the food and drug administration( FDA) issued Inovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products,and it addressed that systematic application of the concept of Model Based Drug Development( MBDD) had the potential to significantly improve drug development. Many guidelines of China food and drug administration( CFDA) recommended the use of MBDD. Specification documentation will guarantee the quality of MBDD results and the high-efficiency of regulatory review. However,there is no unified standard for domestic MBDD documentation specification in China. Based on the white paper of European Federation of Pharmaceutical Industries and Associations( EFPIA),and combined with guidelines of FDA and European Medicines Agency( EMA),this paper put forward some reasonable suggestions on good documentation practice for MBDD to enhance MBDD application in drug development and regulatory assessment,and would be a valuable reference for the industry standards in the future.更多还原