Department of Industrial and Molecular Pharmaceutics, Purdue University, West Lafayette, IN, USA.
Pharm Res. 2024 Aug;41(8):1547-1555. doi: 10.1007/s11095-024-03737-8. Epub 2024 Aug 6.
This paper reviews the accelerated development of pharmaceuticals, exploring past, present, and future perspectives. It provides a historical overview of early strategies used to expedite development, beginning with initiatives from the 1990s. The work of Gardner and Byrn in accelerated development analysis during this era is highlighted. The narrative progresses to the 2000s, discussing the emergence of PK/PD in accelerating pharmaceutical development. The paper further examines case studies in the accelerated development field, including the INDIGO and Chorus programs. It concludes with an analysis of the current state of the field, referencing the NIPTE conference, which focused on the industrial perspective of accelerated development. Additionally, the paper outlines strategies for the rapid development of Solid Lipid Nanoparticle manufacturing and vaccine production.
本文综述了药品开发的加速发展，探讨了过去、现在和未来的观点。它提供了早期加速发展策略的历史概述，从 20 世纪 90 年代的举措开始。强调了 Gardner 和 Byrn 在这一时期加速发展分析中的工作。叙述进展到 21 世纪，讨论了 PK/PD 在加速药物开发中的出现。本文进一步研究了加速开发领域的案例研究，包括 INDIGO 和 Chorus 计划。最后分析了该领域的现状，提到了 NIPTE 会议，该会议重点关注加速开发的工业视角。此外，本文还概述了快速开发固体脂质纳米粒制造和疫苗生产的策略。
