Statistics in Biopharmaceutical Research

英文简介

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.

中文简介

生物医药研究统计(SBR)，发表文章，关注研究人员和应用统计学家在生物医药行业的需求;医学、兽医学、公共卫生和药学学院的生物统计学家;在监管机构(如美国食品和药物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;对采用本刊所载方法有兴趣的统计学家;以及对将统计学方法应用于生物制药问题感兴趣的非统计学家。生物制药研究中的统计学接受讨论有关在制药、生物制药、设备和诊断行业的研究、开发和实践的所有阶段中使用统计学的适当统计方法和信息的论文。文章应侧重于发展新的统计方法，当前方法的新应用，或统计原则的创新应用，可用于这些学科的统计从业人员。应用领域可包括药物发现的统计方法，包括处理多重性、顺序试验、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;生物标志物和代用标志物;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;规管指引，包括术语标准化(例如CDISC)、与制药实践有关的公差和规格限制，以及新的药物批准方法等问题;以及临床和毒理学研究中不良事件的检测。教程文章也是受欢迎的。文章应该包括这个方法有用的可证明的证据(可能通过应用程序)。SBR的编辑委员会打算确保该杂志不断提供重要、有用和及时的信息。为了做到这一点，审计委员会努力吸引优秀的文章，办法是确保每一份提交的文件都得到认真、彻底和迅速的审查。

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