生物醫藥研究統計(SBR),發表文章,關注研究人員和應用統計學家在生物醫藥行業的需求;醫學、獸醫學、公共衛生和藥學學院的生物統計學家;在監管機構(如美國食品和藥物管理局及其在其他國家的對應機構)工作的統計學家和定量分析師;對采用本刊所載方法有興趣的統計學家;以及對將統計學方法應用于生物制藥問題感興趣的非統計學家。生物制藥研究中的統計學接受討論有關在制藥、生物制藥、設備和診斷行業的研究、開發和實踐的所有階段中使用統計學的適當統計方法和信息的論文。文章應側重于發展新的統計方法,當前方法的新應用,或統計原則的創新應用,可用于這些學科的統計從業人員。應用領域可包括藥物發現的統計方法,包括處理多重性、順序試驗、適應性設計等問題的論文;臨床前和臨床研究;基因組學和蛋白質組學;生物測定;生物標志物和代用標志物;藥物歷史模型和分析,包括藥物經濟學、產品生命周期、臨床研究中不良事件的檢測和上市后風險評估;規管指引,包括術語標準化(例如CDISC)、與制藥實踐有關的公差和規格限制,以及新的藥物批準方法等問題;以及臨床和毒理學研究中不良事件的檢測。教程文章也是受歡迎的。文章應該包括這個方法有用的可證明的證據(可能通過應用程序)。SBR的編輯委員會打算確保該雜志不斷提供重要、有用和及時的信息。為了做到這一點,審計委員會努力吸引優秀的文章,辦法是確保每一份提交的文件都得到認真、徹底和迅速的審查。
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.
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