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Introducing the COST Action 'Improving the Quality of Biomedical Science with 3Rs Concepts' (IMPROVE). 介绍 "用 3R 概念提高生物医学科学质量"(IMPROVE)的 COST 行动。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-27 DOI: 10.1177/02611929241286024
Maria Kitsara, Merima Smajlhodžić-Deljo, Lejla Gurbeta Pokvic, Bettina Bert, Nataliia Bubalo, Sevilay Erden, Nuno Henrique Franco, Giuseppe Chirico, Jonathan Gómez Raja, Fernando Gonzalez-Uarquin, Annemarie Lang, Nicole Linklater, Sandra Mojsova, I Anna S Olsson, Ioanna Sandvig, Alexandra Schaffert, Marthe Schmit, Sophie Schober, Bogdan Sevastre, Doris Wilflingseder, Arti Ahluwalia, Winfried Neuhaus
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引用次数: 0
Journeying Through Journals: The Publishing Process and How to Maximise Research Impact. 期刊之旅:出版过程以及如何最大限度地扩大研究影响。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-26 DOI: 10.1177/02611929241286624
Judith C Madden, Helena Kandarova, Winfried Neuhaus, Nikki Osborne, Alicia Paini, Rita Seabra, Susan Trigwell

Publication is essential to share new ideas, knowledge, or recent findings with those who have an interest in a particular area. Selecting the most appropriate format and timing for dissemination is critical to ensuring the long-term impact of research. However, many researchers, particularly those in the early stages of their career, are unaware of how the publication process works and the different options available for promoting research to maximum effect. Understanding how to maximise impact is particularly important for research using animal models or alternative methods, to make the best use of any animal data generated and reduce animal testing in future. Herein, different publishing models are explained, including anonymised peer review, open review and data sharing initiatives. An overview is given of key resources available to assist authors, reviewers and editors in the process of writing, presenting, reviewing and publishing research. New challenges and opportunities in publishing are discussed, including the potential influence of Artificial Intelligence. A list of 'ten top tips' in publishing for early career researchers is presented, providing advice and recommendations for ensuring a successful and impactful publication record.

要与对某一领域感兴趣的人分享新观点、新知识或最新研究成果,发表论文是必不可少的。选择最合适的传播形式和时机对于确保研究的长期影响至关重要。然而,很多研究人员,尤其是处于职业生涯早期阶段的研究人员,并不知道出版流程是如何运作的,也不知道有哪些不同的选择可以最大限度地推广研究成果。了解如何最大限度地扩大影响对于使用动物模型或替代方法的研究尤为重要,这样才能充分利用所产生的动物数据,并在未来减少动物试验。这里将解释不同的出版模式,包括匿名同行评审、公开评审和数据共享计划。概述了在撰写、介绍、评审和出版研究成果的过程中,可为作者、审稿人和编辑提供帮助的主要资源。讨论了出版方面的新挑战和新机遇,包括人工智能的潜在影响。介绍了职业生涯初期研究人员发表论文的 "十大秘诀",为确保成功发表有影响力的论文提供了意见和建议。
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引用次数: 0
An Evaluation of the Replacement of Animal-derived Biomaterials in Human Primary Cell Culture. 评估人类原代细胞培养中动物源生物材料的替代性。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-01 Epub Date: 2024-08-09 DOI: 10.1177/02611929241269004
Laura R Bramwell, Samantha J Gould, Merlin Davies, Conor McMullan, Emily C Trusler, Lorna W Harries

The likelihood that potential new drugs will successfully navigate the current translational pipeline is poor, with fewer than 10% of drug candidates making this transition successfully, even after their entry into clinical trials. Prior to this stage, candidate drugs are typically evaluated by using models of increasing complexity, beginning with basic in vitro cell culture studies and progressing through to animal studies, where many of these candidates are lost due to lack of efficacy or toxicology concerns. There are many reasons for this poor translation, but interspecies differences in functional and physiological parameters undoubtedly contribute to the problem. Improving the human-relevance of early preclinical in vitro models may help translatability, especially when targeting more nuanced species-specific cell processes. The aim of the current study was to define a set of guidelines for the effective transition of human primary cells of multiple lineages to more physiologically relevant, translatable, animal-free in vitro culture conditions. Animal-derived biomaterials (ADBs) were systematically replaced with non-animal-derived alternatives in the in vitro cell culture systems, and the impact of the substitutions subsequently assessed by comparing the kinetics and phenotypes of the cultured cells. ADBs were successfully eliminated from primary human dermal fibroblast, uterine fibroblast, pulmonary fibroblast, retinal endothelial cell and peripheral blood mononuclear cell culture systems, and the individual requirements of each cell subtype were defined to ensure the successful transition toward growth under animal-free culture conditions. We demonstrate that it is possible to transition ('humanise') a diverse set of human primary cell types by following a set of simple overarching principles that inform the selection, and guide the evaluation of new, improved, human-relevant in vitro culture conditions.

潜在新药成功通过当前转化管道的可能性很小,即使在进入临床试验后,也只有不到 10%的候选药物能成功通过转化管道。在这一阶段之前,候选药物通常要使用复杂程度越来越高的模型进行评估,从基本的体外细胞培养研究开始,一直到动物实验,许多候选药物由于缺乏疗效或毒理学问题而在动物实验中夭折。造成这种转化效果不佳的原因有很多,但功能和生理参数的种间差异无疑是造成这一问题的原因之一。提高早期临床前体外模型与人类的相关性可能有助于转化,尤其是在针对更细微的物种特异性细胞过程时。当前研究的目的是为人类多系原代细胞有效过渡到更贴近生理、可转化、无动物的体外培养条件确定一套指导原则。在体外细胞培养系统中,用非动物来源的替代品系统地替代了动物来源的生物材料(ADB),随后通过比较培养细胞的动力学和表型评估了替代品的影响。我们成功地消除了原代人类真皮成纤维细胞、子宫成纤维细胞、肺成纤维细胞、视网膜内皮细胞和外周血单核细胞培养系统中的 ADB,并确定了每种细胞亚型的个体需求,以确保成功过渡到无动物培养条件下的生长。我们证明,通过遵循一系列简单的总体原则,可以过渡("人源化")多种人类原代细胞类型,这些原则为选择和评估新的、改进的、与人类相关的体外培养条件提供了指导。
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引用次数: 0
Conference Diary. 会议日记。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-01 DOI: 10.1177/02611929241274428
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引用次数: 0
Development of Sensitive In Vitro Protocols for the Biocompatibility Testing of Medical Devices and Pharmaceuticals Intended for Contact with the Eyes: Acute Irritation and Phototoxicity Assessment. 开发用于与眼睛接触的医疗设备和药品生物兼容性测试的敏感体外协议:急性刺激和光毒性评估。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-01 Epub Date: 2024-08-21 DOI: 10.1177/02611929241270095
Peter Pôbiš, Júlia Kubalcová, Tatiana Milasová, Helena Kandárová

This study introduces a novel in vitro methodology that employs the 3-D reconstructed tissue model, EpiOcular, to assess the irritation and phototoxicity potential of medical devices and drugs in contact with the eye. Our study evaluated diverse test materials, including medical devices, ophthalmological solutions and an experimental drug (cemtirestat), for their potential to cause eye irritation and phototoxicity. The protocols used in this study with the EpiOcular tissue model were akin to those used in the ultra-mildness testing of cosmetic formulations, which is challenging to predict with standard in vivo rabbit tests. To design these protocols, we leveraged experience gained from the validation project on the EpiDerm skin irritation test for medical devices (ISO 10993-23:2021) and the OECD TG 498 method for photo-irritation testing. The predictions were based on the tissue viability and inflammatory response, as determined by IL-1α release. By developing and evaluating these protocols for medical devices, we aimed to expand the applicability domain of the tests referred to in ISO 10993-23. This will contribute to the standardisation and cost-effective safety evaluation of ophthalmic products, while reducing reliance on animal testing in this field. The findings obtained from the EpiOcular model in the photo-irritation test could support its implementation in the testing strategies outlined in OECD TG 498.

本研究介绍了一种新型体外方法,该方法采用三维重建组织模型 EpiOcular 来评估与眼睛接触的医疗器械和药物的刺激性和光毒性潜力。我们的研究评估了各种测试材料,包括医疗器械、眼科溶液和一种实验药物(cemtirestat),以确定它们是否可能对眼睛产生刺激和光毒性。本研究中使用的 EpiOcular 组织模型类似于化妆品配方超温和性测试中使用的方案,而标准的体内兔试验很难预测这种超温和性。在设计这些方案时,我们充分利用了从医疗器械 EpiDerm 皮肤刺激测试验证项目(ISO 10993-23:2021)和 OECD TG 498 光刺激测试方法中获得的经验。预测的依据是组织活力和炎症反应,由 IL-1α 释放量决定。通过为医疗器械开发和评估这些协议,我们旨在扩大 ISO 10993-23 中所述测试的适用范围。这将有助于眼科产品安全评估的标准化和成本效益,同时减少该领域对动物试验的依赖。EpiOcular 模型在光刺激测试中获得的结果可支持其在 OECD TG 498 中概述的测试策略中的实施。
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引用次数: 0
Editorial. 社论
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-01 Epub Date: 2024-08-07 DOI: 10.1177/02611929241274885
Judith C Madden
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引用次数: 0
Progress and Remaining Opportunities to Increase the Use of Animal-free Antibodies in the USA. 美国在增加使用无动物抗体方面取得的进展和仍然存在的机遇。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-01 Epub Date: 2024-07-24 DOI: 10.1177/02611929241266472
Katherine Groff, David Allen, Warren Casey, Amy J Clippinger

The scientific and ethical issues associated with the use of animal-derived antibodies in research can be overcome by the use of animal-free, sequence-defined recombinant antibodies, whose benefits are well documented. Here, we describe progress made following a 2019 expert meeting focused on improving the quality and reproducibility of biomedical research by accelerating the production and use of animal-free recombinant antibodies in the USA. In the five intervening years since the meeting, participants have established multifaceted initiatives to tackle the next steps outlined during the meeting. These initiatives include: prioritising the replacement of ascites-derived and polyclonal antibodies; distributing educational materials describing recombinant antibodies; fostering public-private partnerships to increase access to recombinant antibodies; and increasing the availability of funding for recombinant antibody development. Given the widescale use of antibodies across scientific disciplines, a transition to modern antibody production methods relies on a commitment from government agencies, universities, industry and funding organisations, to initiatives such as those outlined here.

在研究中使用源于动物的抗体所带来的科学和伦理问题可以通过使用无动物、序列明确的重组抗体来解决,重组抗体的好处有据可查。在此,我们介绍了 2019 年专家会议之后取得的进展,会议的重点是通过加快美国无动物重组抗体的生产和使用,提高生物医学研究的质量和可重复性。在会议召开后的五年间,与会者制定了多方面的举措,以解决会议期间概述的下一步问题。这些措施包括:优先替代腹水衍生抗体和多克隆抗体;分发介绍重组抗体的教育材料;促进公私合作以增加重组抗体的使用;增加重组抗体开发的资金供应。鉴于抗体在各科学学科中的广泛应用,向现代抗体生产方法的过渡有赖于政府机构、大学、产业界和资助组织对本文概述的倡议做出承诺。
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引用次数: 0
Conference Diary. 会议日记。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-01 Epub Date: 2024-06-12 DOI: 10.1177/02611929241260577
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引用次数: 0
2023 Michael Balls Award. 2023 年迈克尔-鲍尔斯奖
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-01 DOI: 10.1177/02611929241262162
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引用次数: 0
An Accessible Nephrectomy and Cystotomy Simulator for Use in Teaching Small Animal Surgery. 用于小动物外科教学的无障碍肾切除术和膀胱切除术模拟器。
IF 2.4 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-01 DOI: 10.1177/02611929241265103
Matheus Barbosa Gomes Cruz, Lyana Costa, Roberta Carareto, Simone Tostes de Oliveira Stedile

The use of simulators in veterinary education has been increasing over the last few years. This is fundamental for surgical classes, as simulators can provide a better learning environment for the students. Two procedures commonly taught in veterinary surgical practical classes are nephrectomy and cystotomy. However, the lack of simulators for use in these classes limits the training options to the use of cadavers, which have a number of associated disadvantages, including the potential for autolysis. The aim of this study was to develop and assess the value of a simple nephrectomy and cystotomy simulator that could replace the use of cadavers in surgical practical classes. The simulator, which represented the abdominal cavity, bladder, kidneys, ureter, vessels and adipose tissue, was constructed by using synthetic materials. To evaluate its usefulness and acceptance by the students, the learning outcomes and student satisfaction, for both the simulator and an ethically sourced dog cadaver, were compared. The students completed a Likert scale questionnaire, and the answers were evaluated by using the Diagnostic Content Validation (DCV) model. The simulator was well accepted by the students, with the best scores achieved for the ureter divulsion and ligation procedures; good results were also recorded for the kidney vessel ligature and urinary bladder suture practice. The scores showed that the simulator provided an acceptable experience during the training process and increased the confidence of the students in performing the procedure.

在过去几年里,兽医教育中模拟器的使用越来越多。这对于外科手术课来说至关重要,因为模拟器可以为学生提供更好的学习环境。兽医外科实践课上通常教授的两个程序是肾切除术和膀胱切开术。然而,由于缺乏可用于这些课程的模拟器,培训只能选择使用尸体,而尸体有许多相关的缺点,包括可能发生自溶。本研究的目的是开发和评估简单肾切除术和膀胱切开术模拟器的价值,以取代外科实践课程中尸体的使用。该模拟器由合成材料制成,代表了腹腔、膀胱、肾脏、输尿管、血管和脂肪组织。为了评估模拟器的实用性和学生的接受程度,我们对模拟器和一具符合道德标准的狗尸体的学习效果和学生满意度进行了比较。学生们填写了一份李克特量表问卷,并使用诊断内容验证(DCV)模型对答案进行了评估。学生们对模拟器的接受度很高,其中输尿管剥离和结扎手术得分最高;肾血管结扎和膀胱缝合练习也取得了不错的成绩。得分情况表明,模拟器在培训过程中提供了可接受的体验,增强了学生进行手术的信心。
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Atla-Alternatives To Laboratory Animals
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