期刊简介
Statistics in Biopharmaceutical Research ( SBR), publishes articles that focus on the needs of researchers and applied statisticians in biopharmaceutical industries; academic biostatisticians from schools of medicine, veterinary medicine, public health, and pharmacy; statisticians and quantitative analysts working in regulatory agencies (e.g., U.S. Food and Drug Administration and its counterpart in other countries); statisticians with an interest in adopting methodology presented in this journal to their own fields; and nonstatisticians with an interest in applying statistical methods to biopharmaceutical problems.Statistics in Biopharmaceutical Research accepts papers that discuss appropriate statistical methodology and information regarding the use of statistics in all phases of research, development, and practice in the pharmaceutical, biopharmaceutical, device, and diagnostics industries. Articles should focus on the development of novel statistical methods, novel applications of current methods, or the innovative application of statistical principles that can be used by statistical practitioners in these disciplines. Areas of application may include statistical methods for drug discovery, including papers that address issues of multiplicity, sequential trials, adaptive designs, etc.; preclinical and clinical studies; genomics and proteomics; bioassay; biomarkers and surrogate markers; models and analyses of drug history, including pharmacoeconomics, product life cycle, detection of adverse events in clinical studies, and postmarketing risk assessment; regulatory guidelines, including issues of standardization of terminology (e.g., CDISC), tolerance and specification limits related to pharmaceutical practice, and novel methods of drug approval; and detection of adverse events in clinical and toxicological studies. Tutorial articles also are welcome. Articles should include demonstrable evidence of the usefulness of this methodology (presumably by means of an application).The Editorial Board of SBR intends to ensure that the journal continually provides important, useful, and timely information. To accomplish this, the board strives to attract outstanding articles by seeing that each submission receives a careful, thorough, and prompt review.Authors can choose to publish gold open access in this journal.
《生物制药研究中的统计学》（SBR），发表文章，重点关注生物制药行业研究人员和应用统计学家的需求;医学、兽医学、公共卫生和药学院的学术生物统计学家;在管理机构（例如，美国食品药品监督管理局及其在其他国家的对应机构）;统计学家有兴趣采用本杂志介绍的方法，以自己的领域;和非统计学家，对应用统计学方法解决生物制药问题感兴趣。2生物制药研究中的统计学接受讨论适当的统计学方法和信息的论文，这些信息涉及在制药、生物制药、设备和诊断工业的研究、开发和实践的所有阶段中使用统计学。文章应该关注新的统计方法的发展，当前方法的新应用，或统计原理的创新应用，这些统计原理可以被这些学科的统计从业者使用。应用领域可能包括药物发现的统计方法，包括解决多重性、序贯试验、适应性设计等问题的论文;临床前和临床研究;基因组学和蛋白质组学;生物测定;生物标记物和替代标记物;药物历史的模型和分析，包括药物经济学、产品生命周期、临床研究中不良事件的检测和上市后风险评估;管理准则，包括术语标准化问题（例如，CDISC）、与制药实践相关的容许限度和质量标准限度以及新的药物批准方法;和毒理学研究中不良事件的检测。教程文章也是受欢迎的。论文应包括证明该方法有用性的证据（可能通过应用程序）。SBR编辑委员会旨在确保期刊持续提供重要、有用和及时的信息。为了实现这一目标，委员会努力吸引优秀的文章，确保每一个提交收到仔细，彻底，并迅速审查。作者可以选择发表黄金开放获取在本杂志。
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