一致性评价是要求已经批准上市的仿制药,按与原研药品质量和疗效一致的原则开展评价。这是在补历史的课,也是提高仿制药质量、发展仿制药的重要一步。 仿制药一致性评价并非我国独有,美国、日本等国家也都经历了同样的过程,比如日本用了十几年时间推进仿制药一致性评...
consistency evaluation
1、fda仿制药一致性评价指导指南(中英文版)guidance for industry controlled correspondence related to generic drugdevelopment行业指南:有关仿制药研发的书面询问this guidance represents the current thinking of the food and drug administration (fda, or the agency) on this topic. it does not establish any ...
fdagdufa指南制药英文版一致性 SoltorisManagementConsultants,Inc.洛施德企业管理咨询(上海)有限公司第1页/共18页.soltoris,SoltorisManagementConsultants,Inc.info@soltorisGuidanceforIndustryControlledCorrespondenceRelatedtoGenericDrugDevelopment行业指南:有关仿制药研发的书面咨询Thisguidancerepresentsthecurrentthinkingofthe...
consistency evaluation
仿制药一致性评价并非我国独有,美国、日本等国家也都经历了同样的过程,比如日本用了十几年时间推进仿制药一致性评价工作。 仿制药一致性评价的最终目的是要实现在临床上对原研药的可替代性。 原研药 branded drug、brand-name drug 解释: 我国药品监督管理局给出的释义是:原研药,即过了专利期的、由原生产商生产...
FDA仿制药一致性评价指导指南(中英文版) Guidance for Industry Controlled Correspondence Related to Generic Drug Development 行业指南:有关仿制药研发的书面询问 This guidance represents the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish ...
FDA仿制药一致性评价指导指南(中英文版) Guidance for Industry Controlled Correspondence Related to Generic Drug Development 行业指南:有关仿制药研发的书面询问 This guidance represents the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish ...
Development 行业指南:有关仿制药研发的书面咨询 This guidance represents the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach...