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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。
The use of model evaluation methods in new drug research and development, that is, quantitative pharmacological methods, has been recognized and supported by relevant regulatory agencies. As early as 2004, the U.S. Food and Drug Administration (FDA) white paper entitled “Opportunities and Challenges in the Critical Path of New Pharmaceutical Products,” has put the concept of model-based drug discovery (MBDD) as one of the opportunities to improve drug development , The State Food and Drug Administration (CFDA) also has guidelines recommending the MBDD method. Standardized documentation can guarantee the quality and efficient evaluation of the results of MBDD, but at present, there is no standard for documenting MBDD in China. In this paper, based on the model-mediated drug development (MID3) white paper and the guidance of the FDA and the European Medicines Agency (EMA) released by the European Federation of Pharmaceutical Industry Associations (EFPIA), reasonable suggestions are put forward on document preparation for the MBDD specification, Write for reference.