加速药品开发的过去、现在和未来。

IF 3.5 3区医学 Q2 CHEMISTRY, MULTIDISCIPLINARY

Pharmaceutical Research Pub Date : 2024-08-01 Epub Date: 2024-08-06 DOI:10.1007/s11095-024-03737-8

Stephen R Byrn

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引用次数: 0

摘要

本文回顾了药品的加速开发，探讨了过去、现在和未来的前景。它从历史角度概述了从 20 世纪 90 年代开始用于加速开发的早期战略。重点介绍了 Gardner 和 Byrn 在这一时期的加速开发分析工作。到了 2000 年代，本文讨论了 PK/PD 在加速药物开发中的应用。论文进一步探讨了加速开发领域的案例研究，包括 INDIGO 和 Chorus 计划。最后，论文分析了该领域的现状，并参考了 NIPTE 会议，该会议的重点是加速开发的工业视角。此外，论文还概述了固体脂质纳米粒子制造和疫苗生产的快速发展战略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Accelerated Development of Pharmaceuticals Past, Present, and Future.

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Accelerated Development of Pharmaceuticals Past, Present, and Future.

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.

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来源期刊

Pharmaceutical Research 医学-化学综合

CiteScore

6.60

自引率

5.40%

发文量

276

审稿时长

3.4 months

期刊介绍： Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.