Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

被引:0
作者
Rajanikanth Madabushi
Paul Seo
Liang Zhao
Million Tegenge
Hao Zhu
机构
[1] Office of Clinical Pharmacology,
[2] Office of Translational Sciences,undefined
[3] Center for Drug Evaluation and Research,undefined
[4] US Food and Drug Administration,undefined
[5] Division of Biopharmaceutics,undefined
[6] Office of New Drug Products,undefined
[7] Office of Pharmaceutical Quality,undefined
[8] Center for Drug Evaluation and Research,undefined
[9] US Food and Drug Administration,undefined
[10] Division of Quantitative Methods and Modeling,undefined
[11] Office of Research and Standards,undefined
[12] Office of Generic Drugs,undefined
[13] Center for Drug Evaluation and Research,undefined
[14] US Food and Drug Administration,undefined
[15] Division of Clinical Evaluation and Pharmacology/Toxicology,undefined
[16] Office of Tissue and Advanced Therapies,undefined
[17] Center for Biologics Evaluation and Research,undefined
[18] US Food and Drug Administration,undefined
来源
Pharmaceutical Research | 2022年 / 39卷
关键词
biopharmaceutics; generic drugs; gene therapy; model-informed drug development; new drugs;
D O I
暂无
中图分类号
学科分类号
摘要
Model-informed drug development (MIDD) is a powerful approach to support drug development and regulatory review. There is a rich history of MIDD applications at the U.S. Food and Drug Administration (FDA). MIDD applications span across the life cycle of the development of new drugs, generics, and biologic products. In new drug development, MIDD approaches are often applied to inform clinical trial design including dose selection/optimization, aid in the evaluation of critical regulatory review questions such as evidence of effectiveness, and development of policy. In the biopharmaceutics space, we see a trend for increasing role of computational modeling to inform formulation development and help strategize future in vivo studies or lifecycle plans in the post approval setting. As more information and knowledge becomes available pre-approval, quantitative mathematical models are becoming indispensable in supporting generic drug development and approval including complex generic drug products and are expected to help reduce overall time and cost. While the application of MIDD to inform the development of cell and gene therapy products is at an early stage, the potential for future application of MIDD include understanding and quantitative evaluation of information related to biological activity/pharmacodynamics, cell expansion/persistence, transgene expression, immune response, safety, and efficacy. With exciting innovations on the horizon, broader adoption of MIDD is poised to revolutionize drug development for greater patient and societal benefit.
引用
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页码:1669 / 1680
页数:11
相关论文
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