Drug Development Considerations for Additives to Organ Preservation Solutions.

IF 5.3 2区医学 Q1 IMMUNOLOGY

Transplantation Pub Date : 2024-10-08 DOI:10.1097/TP.0000000000005221

Matthew O'Brien Laramy, Jamie Robinson, C J Venkatramani, Stephanie Horn, Carine Steiner, Yoen-Ju Son

引用次数: 0

Abstract

The addition of a novel therapeutic agent to an organ preservation solution has the potential to address unmet needs in organ transplantation and enhance outcomes for transplant recipients. However, the development expectations for novel therapeutic agents in this context are unclear because of limited precedence and published regulatory guidance documents. To address these gaps, we have articulated a drug development strategy that leverages expectations for parenteral drug products administered via more conventional routes (eg, intravenous) and provided considerations for when deviations may be justified. We have supplemented this strategy with a comparison to available regulatory guidance from the US Food and Drug Administration to highlight potential areas for further clarification. The strategy articulated here is based on Genentech's internal experience for a program intended for use in kidney transplantation.

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器官保存解决方案添加剂的药物开发考虑因素。

在器官保存方案中添加新型治疗剂有可能解决器官移植中尚未满足的需求，并提高移植受者的治疗效果。然而，由于先例和已发布的监管指导文件有限，在这种情况下对新型治疗剂的开发预期尚不明确。为了弥补这些不足，我们阐述了一种药物开发策略，该策略借鉴了通过更常规途径（如静脉注射）给药的肠外药物产品的预期，并对何时有理由偏离预期进行了考虑。我们将这一策略与美国食品药品管理局的现有监管指南进行了比较，以强调需要进一步澄清的潜在领域。本文阐述的策略是基于基因泰克公司内部用于肾移植项目的经验。

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

Transplantation 医学-免疫学

CiteScore

8.50

自引率

11.30%

发文量

1906

审稿时长

1 months

期刊介绍： The official journal of The Transplantation Society, and the International Liver Transplantation Society, Transplantation is published monthly and is the most cited and influential journal in the field, with more than 25,000 citations per year. Transplantation has been the trusted source for extensive and timely coverage of the most important advances in transplantation for over 50 years. The Editors and Editorial Board are an international group of research and clinical leaders that includes many pioneers of the field, representing a diverse range of areas of expertise. This capable editorial team provides thoughtful and thorough peer review, and delivers rapid, careful and insightful editorial evaluation of all manuscripts submitted to the journal. Transplantation is committed to rapid review and publication. The journal remains competitive with a time to first decision of fewer than 21 days. Transplantation was the first in the field to offer CME credit to its peer reviewers for reviews completed. The journal publishes original research articles in original clinical science and original basic science. Short reports bring attention to research at the forefront of the field. Other areas covered include cell therapy and islet transplantation, immunobiology and genomics, and xenotransplantation.