Human biological sample biobanking to support tissue biomarkers in pharmaceutical research and development.
Human biological sample biobanking to support tissue biomarkers in pharmaceutical research and development.
复制标题
人体生物样本生物库支持药物研究和开发中的组织生物标志物。
DOI：
10.1016/j.ymeth.2014.01.014
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发表时间：
2014
期刊：
影响因子：
4.8
通讯作者：
S. Mager
中科院分区：
文献类型：
--
作者：
R. Mager;C. Womack;S. Mager
对分子病理学的理解的进步，以及因此可能适用于治疗操作的机制，是药物研究和开发越来越多地关注于人类生物样品中分子生物标志物的测量的原因。获得直接或间接获得足够的样本，适合研究目的可能是一个主要的挑战。生物库基础设施在获取、储存和使用人类生物样本方面发挥着重要作用，在这里我们回顾了建立生物库的一些关键要求。这些措施包括确保；适当的治理机制到位，可用的样本是适当的，适合预期的研究目的，基础设施在未来是可持续的，生物银行资产的使用符合主办组织的战略目标。最后，我们提出了一个案例研究——STRATUM项目，该项目最近完成，并通过一种涉及六个行业和公共合作伙伴的合作方式，利用专家网络，研究了生物银行政策，公众对生物银行的态度，捐赠者同意，样本和数据标准，注册的技术要求和生物银行的金融模式，尽管是从英国的角度来看。
Advances in the understanding of molecular pathology and thereby the mechanisms that could be amenable to therapeutic manipulation are the reason that pharmaceutical research and development is focused increasingly on measurement of molecular biomarkers in human biological samples. Obtaining direct or indirect access to sufficient samples that are fit for research purposes can be a major challenge. A biobanking infrastructure has a significant role in the acquisition, storage and usage of human biological samples and here we review some key requirements for establishing a biobank. These include ensuring; that appropriate governance mechanisms are in place, that samples available are appropriate and fit for the intended research purposes that the infrastructure is sustainable in the future and that use of the biobank assets meets the strategic aims of the host organisation. Finally we present a case study – the STRATUM project which has recently completed and through a collaborative approach involving six industry and public partners drawing on a network of experts, examined biobank policies, public attitudes to biobanking, donor consent, sample and data standards, technical requirements for a register and biobanking financial models, albeit from a UK perspective.
美国国家临床生物化学研究院实验室医学实践指南在临床实践中使用肿瘤标志物：质量要求。
影响因子：
9.3
作者：
Sturgeon CM;Hoffman BR;Chan DW;Ch'ng SL;Hammond E;Hayes DF;Liotta LA;Petricoin EF;Schmitt M;Semmes OJ;Söletormos G;van der Merwe E;Diamandis EP;National Academy of Clinical Biochemistry
通讯作者：
National Academy of Clinical Biochemistry