期刊名称：STATISTICS IN BIOPHARMACEUTICAL RESEARCH
 期刊简介(About the journal)
投稿须知(Instructions to Authors)
编辑部信息(Editorial Board)
About the journal
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.
Statistics in Biopharmaceutical Research (SBR ) is indexed in:
- Biological Abstracts
- BIOSIS Previews
- Biotechnology Citation Index
- Current Index to Statistics
- EBSCO Discovery
- Google Scholar
- Journal Citation Reports/Science Edition
- Science Citation Index Expanded (also known as SciSearch)
- SCOPUS
- STMA-Z
Instructions to Authors
This journal uses ScholarOne Manuscripts (previously Manuscript Central) to peer review manuscript submissions. Please read the guide for ScholarOne authors before making a submission. Complete guidelines for preparing and submitting your manuscript to this journal are provided below.
Please note that Statistics in Biopharmaceutical Research uses CrossCheck™ software to screen papers for unoriginal material. By submitting your paper to Statistics in Biopharmaceutical Research you are agreeing to any necessary originality checks your paper may have to undergo during the peer review and production processes.
Information for Authors
Important Notice to Authors: To submit a NEW manuscript to Statistics in Biopharmaceutical Research , please go to ASA's ScholarOne Site and select SBR from the drop-down box. Please note that you may already have an account on that site. Just enter your email address.
Editorial Policy
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.
The journal accepts papers discussing 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.
Submitting Manuscripts
Submission of a manuscript for consideration is taken as representation that the manuscript has not been published previously and is not under review for publication elsewhere.
To submit a NEW manuscript to Statistics in Biopharmaceutical Research , please go to
ASA's ScholarOne Site and select SBR from the drop-down box. Please note that you may already have an account on that site. Just enter your email address.
Questions regarding manuscript content should be addressed to Editor Steve Snapinn . Questions regarding AllenTrack submissions should be sent to editorial coordinator Jina Lee .
Authors should submit the following files:
- one PDF file of the blinded manuscript;
- one PDF file of the unblinded manuscript; and
- a text file containing the names of the author(s), abstract, and key words.
Upon final acceptance for publication, a LaTeX, Word, or other text file of the full text (without figures), along with individual files for all figures, will be required.
SBR uses a double-blind reviewing process. Referees are not informed of the name or institution of the authors of submitted manuscripts. Therefore, we request that two versions of the manuscript be supplied---a full version and another version with all marks that might identify the authors or their institutions removed; any identifiable sources of support should be removed along with obvious references to one’s own previous work.
The manuscript should be prepared using 8 1/2 x 11-inch pages, double-spaced—including key words and references—with margins of at least one inch around all sides. Normal-sized fonts (e.g., 11 pt. or 12 pt.) should be used; the use of very small letters to save space is especially discouraged. Pages should be numbered consecutively. Authors are encouraged to use LaTeX if possible, and should use the “article” style, avoiding the use of any special macros. Use of BiBTeX is encouraged, but authors should submit the .bbl file when supplying source files following final acceptance. The manuscript should contain an abstract (see the abstracts paragraph) and from three to six key words or phrases (that do not appear in the title) in alphabetical order. For published manuscripts, these key words will be used—in addition to the title—for indexing in Current Index to Statistics .
Abstracts
Each manuscript should contain an abstract of about 200 words. The abstract is the most important part of any manuscript because it reaches large numbers of browsing readers. It is mandatory that authors pay great attention to the content and language of the abstract. The first part of the abstract should describe the manuscript’s motivation and contribution succinctly. For the benefit of SBR ’s readership, the remainder of the abstract should amplify and illustrate, preferably using concrete examples and interesting special cases.
General Comments on Style
Do not use footnotes, and avoid abbreviations. Represent exponentials by “exp( ).” Write fractions in text using a solidus—for example, (w + x)/(y + z). Do not use overbars extending over more than one character, or underbars. Use boldface for each symbol representing a vector or matrix. Avoid confusion between ambiguous characters (e.g., between lowercase “el” and one or zero and uppercase “oh”). Specific comments about mathematical material are provided in the ASA Style Guide .
Length of Manuscripts
There is no maximum length for manuscripts, but it is much more difficult and time-consuming to get reviews for long manuscripts. An efficient writing style with selective use of tables and figures is appreciated. Manuscripts accepted for publication rarely have more than 25 double-spaced pages, including text, figures, tables, and references.
Figures and Tables
Tables and figures should appear in the body of the manuscript as soon as possible following their first reference, not in separate files nor at the end after the bibliography. Authors should provide extensive legends for their figures and tables to facilitate browsing and decoding of their content. Figures and tables should be numbered consecutively at the top of the page with Arabic numerals and should be titled and labeled clearly. Once a manuscript is accepted for publication, the authors should submit electronic versions of all figures. Figures may be in .ps, .eps, .tif, .gif, or .jpg formats. Please Eric Sampson with questions regarding figure preparation or format.
Data
Whenever a dataset is used, its source should be documented fully. When it is not practical to include the whole of a dataset in the manuscript, the manuscript should state how the complete dataset can be obtained. Authors are encouraged to submit such datasets as supplements to their articles. Exceptions for reasons of security or confidentiality may be granted by the editor.
The ASA's general guidelines on submission of code, data, and supplements can be found here.
Appendices
Lengthy technical portions of a manuscript should appear in a separate appendix to the manuscript. The appendixes should be submitted as supplements to the manuscript.
References
References are to be cited in text with the authors’ names and dates of publication. We discourage the use of inessential unpublished or obscure references. Personal communications are listed in the text only. Do not abbreviate journal titles. Other details for listing and citing references are given in the ASA Style Guide .
Copyright
SBR is copyrighted, and authors must sign a copyright transfer and disclosure form before publication the corresponding author must sign a copyright transfer form on behalf of all authors prior to publication. Each author of a manuscript must sign and submit a disclosure form. U.S. government employees are exempt from this requirement if the work is part of their official duties. ASA's copyright agreement complies with the requirements of NIH-funded works. NOTE: SBR authors may place the submitted, author-prepared version of their manuscript on their own web page or on a public digital repository.
As part of its author services program, ASA’s publishing partner Taylor & Francis will deposit to PubMed Central (PMC) author manuscripts on behalf of authors reporting NIH funded research. The corresponding author will receive proofs for review. At that time, the corresponding author will be able to enter NIH grant information for all contributing authors via the Central Article Tracking system (CATS). Taylor & Francis will deliver to PMC the final peer-reviewed manuscript. Taylor & Francis will also authorize the author manuscript’s public access posting 12 months after final publication in print or electronic form (whichever is the sooner). Following the deposit by Taylor & Francis, authors will receive further communications from the NIH with respect to the submission.
Authors will receive a copyright transfer form upon a manuscript's acceptance.
Accepted Manuscripts Online (AMO)
Manuscripts submitted to the journal are eligible for rapid online posting if a valid copyright form is received and nothing is missing from the paper. The original manuscript will be available on Taylor & Francis Online in a section on the journal’s page entitled “Latest Articles.” Posted papers will be clearly labeled as the “Accepted, uncorrected manuscript” versions and will include DOI numbers so that the papers can be cited and referenced. Authors will also receive notification from Taylor & Francis when the manuscript is posted, when typeset proofs are available, and once again when the final version is posted. The papers in this section will be removed once the edited and final typeset version is posted online.
Proofs
Page proofs are sent to the designated corresponding author using Taylor & Francis’ Central Article Tracking System (CATS). They must be carefully checked and returned within 48 hours of receipt.
NIH Funding - As part of its author services program, Taylor & Francis will deposit to PubMed Central (PMC) author manuscripts on behalf of authors reporting NIH funded research. The corresponding author will be able to enter NIH grant information for all contributing authors via CATS. Taylor & Francis will deliver to PMC the final peer-reviewed manuscript. Taylor & Francis will also authorize the author manuscript’s public access posting 12 months after final publication in print or electronic form (whichever is the sooner). Following the deposit by Taylor & Francis, authors will receive further communications from the NIH with respect to the submission.
Reprints - Authors for whom we receive a valid email address will be provided an opportunity to purchase reprints of individual articles, or copies of the complete print issue. These authors will also be given complimentary access to their final article on Taylor & Francis Online.
Plagiarism
The ASA observes a policy of zero tolerance in cases of malfeasance by authors. These acts include plagiarism and submitting nearly identical papers to different publications. Authors who engage in these acts will have their papers rejected and their institution will be notified of the rejection and its motivation.
Editorial Board
Editor
Editorial Coordinator
Associate Editors
Stan Altan - Johnson & Johnson
Gregory Campbell - U.S. Food and Drug Administration
Ivan Chan - Merck
Cong Chen - Merck
Michael Chernick - Lankenau Institute for Medical Research
Avital Cnaan - Children's National Medical Center
Paul Gallo - Novartis
Daniel Heitjan - University of Pennsylvania
Antje Hoering - Cancer Research and Biostatistics
Boris Iglewicz - Temple University
Qi Jiang - Amgen Inc
Jose Pinheiro - Johnson and Johnson
Brian Smith - Amgen
Roy Tamura - University of South Florida
Brian Wiens - Alcon Laboratories
Yan (Daniel) Zhao - University of Oklahoma Health Sciences Center
Journals Manager
Eric Sampson
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