中文簡介

生物醫(yī)藥研究統(tǒng)計(jì)(SBR)，發(fā)表文章，關(guān)注研究人員和應(yīng)用統(tǒng)計(jì)學(xué)家在生物醫(yī)藥行業(yè)的需求;醫(yī)學(xué)、獸醫(yī)學(xué)、公共衛(wèi)生和藥學(xué)學(xué)院的生物統(tǒng)計(jì)學(xué)家;在監(jiān)管機(jī)構(gòu)(如美國食品和藥物管理局及其在其他國家的對應(yīng)機(jī)構(gòu))工作的統(tǒng)計(jì)學(xué)家和定量分析師;對采用本刊所載方法有興趣的統(tǒng)計(jì)學(xué)家;以及對將統(tǒng)計(jì)學(xué)方法應(yīng)用于生物制藥問題感興趣的非統(tǒng)計(jì)學(xué)家。生物制藥研究中的統(tǒng)計(jì)學(xué)接受討論有關(guān)在制藥、生物制藥、設(shè)備和診斷行業(yè)的研究、開發(fā)和實(shí)踐的所有階段中使用統(tǒng)計(jì)學(xué)的適當(dāng)統(tǒng)計(jì)方法和信息的論文。文章應(yīng)側(cè)重于發(fā)展新的統(tǒng)計(jì)方法，當(dāng)前方法的新應(yīng)用，或統(tǒng)計(jì)原則的創(chuàng)新應(yīng)用，可用于這些學(xué)科的統(tǒng)計(jì)從業(yè)人員。應(yīng)用領(lǐng)域可包括藥物發(fā)現(xiàn)的統(tǒng)計(jì)方法，包括處理多重性、順序試驗(yàn)、適應(yīng)性設(shè)計(jì)等問題的論文;臨床前和臨床研究;基因組學(xué)和蛋白質(zhì)組學(xué);生物測定;生物標(biāo)志物和代用標(biāo)志物;藥物歷史模型和分析，包括藥物經(jīng)濟(jì)學(xué)、產(chǎn)品生命周期、臨床研究中不良事件的檢測和上市后風(fēng)險(xiǎn)評估;規(guī)管指引，包括術(shù)語標(biāo)準(zhǔn)化(例如CDISC)、與制藥實(shí)踐有關(guān)的公差和規(guī)格限制，以及新的藥物批準(zhǔn)方法等問題;以及臨床和毒理學(xué)研究中不良事件的檢測。教程文章也是受歡迎的。文章應(yīng)該包括這個(gè)方法有用的可證明的證據(jù)(可能通過應(yīng)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(shí)的信息。為了做到這一點(diǎn)，審計(jì)委員會努力吸引優(yōu)秀的文章，辦法是確保每一份提交的文件都得到認(rèn)真、徹底和迅速的審查。

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英文簡介

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.