Statistics in Biopharmaceutical Research

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.

【译文】《生物制药研究统计》（SBR）发表专注于生物制药行业研究人员和应用统计学家需求的文章；来自医学院、兽医学院、公共卫生学院和药学院的学术生物统计学家；在监管机构（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）工作的统计学家和定量分析师；对采用本刊提出的方法论感兴趣并应用于自己领域的统计学家；对将统计方法应用于生物制药问题感兴趣的非统计学家。SBR接受讨论适当统计方法以及关于在制药、生物制药、设备和诊断行业研究、开发和实践中使用统计信息的论文。文章应侧重于新型统计方法的发展、现有方法的创新应用或统计原理的创新应用，这些原理可以由这些学科领域的统计实践者使用。应用领域可能包括药物发现中的统计方法，包括解决多重性、序贯试验、适应性设计等问题；临床前和临床研究；基因组学和蛋白质组学；生物测定；生物标志物和替代标志物；药物历史模型和分析，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；监管指南，包括术语标准化问题（例如，CDISC）、与制药实践相关的公差和规格限制以及新型药物审批方法；以及临床和毒理学研究中不良事件的检测。也欢迎教程文章。文章应包括该方法的实用性的证明（可能通过应用来实现）。SBR的编委会旨在确保该期刊持续提供重要、有用和及时的信息。为此，委员会努力吸引杰出的文章，确保每篇投稿都得到仔细、全面和及时的审阅。作者可以选择在本刊发表金色开放获取。