Translation from ophthalmic research to ophthalmic products.

IF 4.1 1区医学 Q1 OPHTHALMOLOGY

American Journal of Ophthalmology Pub Date : 2025-05-09 DOI:10.1016/j.ajo.2025.05.001

Gary D Novack,William J Brock,Audrey R Schupp

引用次数: 0

Abstract

PURPOSE To provide guidance primarily for the academic researcher for the translation from research of novel ophthalmic drugs for improved patient treatment to early stage development including clinical trials METHODS: Based upon available guidelines and the authors' extensive experience in developing novel products, the authors present the requirements for chemistry (both drug substance and formulated drug product), nonclinical (pharmacology, pharmacokinetics, and toxicology), clinical and regulatory development. CONCLUSION Development of successful novel ophthalmic products is a structured, sequential and interactive scientific process.

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从眼科研究到眼科产品的翻译。

目的：主要为学术研究人员提供指导，帮助他们从改善患者治疗的眼科新药研究转向包括临床试验在内的早期开发。根据现有的指南和作者在开发新产品方面的丰富经验，作者提出了化学（原料药和制剂药物）、非临床（药理学、药代动力学和毒理学）、临床和监管开发的要求。结论成功的新型眼科产品的开发是一个有条理、有序、互动的科学过程。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Ophthalmology 医学-眼科学

CiteScore

9.20

自引率

7.10%

发文量

406

审稿时长

36 days

期刊介绍： The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect. The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports. Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.