Aims and Scope: The journal will provide an information resource for applied statisticians working in biopharmaceutical areas through publication of (i) high quality application of statistics in biopharmaceutical research and development and (ii) expositions of statistical methodology with clear and immediate applicability to such work.
The journal welcomes the submission of publications addressing the solutions of problems arising at all stages of the biopharmaceutical development process. Biopharmaceutical applications include the processes of research and development of drugs, devices, and biologics. Statistical aspects of the strategic process for choosing developmental candidates; drug screening, especially modern techniques; assessment of pharmacological activity; pharmaceutical formulation and scale-up; pre-clinical safety assessment; bioavailability, bioequivalence, and pharmacokinetics and pharmacodynamics, genomics, and biomarker development; phase I, II, and III clinical development: pre-market approval assessment of clinical safety; post-marketing surveillance; manufacturing and quality control; technical operations; pharmacoepidemiology; quality of life; health economics; commercial development of the product after approval; and regulatory issues comprise a non-exhaustive list of applications. While the application of methods to the problems that motivated them is the major focus of the journal, descriptions of new methods or of novel and insightful applications of existing methods also are appropriate as long as their value for addressing the original problem is clearly described. Substantive aspects of the application should be presented. The process of problem formulation appropriate to the statistical method should be specifically addressed. In reflecting applied statistics as a scientific discipline, the journal hopes to provide models in the biopharmaceutical areas of proper design, analysis, and interpretation of both experimental and observational studies.
Submission of Manuscripts: The
Journal of Biopharmaceutical Statistics receives all manuscript submissions electronically via their Manuscript Central website located at
http://mc.manuscriptcentral.com/LBPS. Manuscript Central allows for rapid submission of original and revised manuscripts, as well as facilitating the review process and internal communication between authors, editors and reviewers via a web-based platform. For Manuscript Central technical support, you may contact them by e-mail or phone support via
http://mcv3support.custhelp.com.
If you have any other requests please contact the journal at sheinchung.chow@duke.edu. Each manuscript must be accompanied by a statement that it has not been published elsewhere and that it has not been submitted simultaneously for publication elsewhere. Authors are responsible for obtaining permission to reproduce copyrighted material from other sources and are required to sign an agreement for the transfer of copyright to the publisher. All accepted manuscripts, artwork, and photographs become the property of the publisher.
All parts of the manuscript should be typewritten, double-spaced, with margins of at least one inch on all sides. Number manuscript pages consecutively throughout the paper. Authors should also supply a shortened version of the title suitable for the running head, not exceeding 50 character spaces. Each article should be summarized in an abstract of not more than 100 words. Avoid abbreviations, diagrams, and reference to the text in the abstract. To ensure blind review, please upload a blinded text as well as a separate title page file that includes acknowledgements and any author information.
References. Cite references in the text by author and date (Smith, 1983). References list should be in alphabetical order at the end of the article. Examples:
Journal: Armitage, P., McPherson, C. K., Rowe, B. C. (1969). Repeated significance tests on accumulating dats. J. Roy. Statist. Soc. A132:235-244.
Book: Vonesh, E. F., Chinchilli, V. M. (1997). Linear and Nonlinear Models for the Analysis of Repeated Measurements. New York: Marcel Dekker.
Government Publication: Hothem, R. L.; DeHaven, R. W.; Fairaizl, S. D. (1988). Damage to Sunflower in North Dakota, South Dakota, and Minnesota, 1979-1981, Fish and Wildlife Technical Report 15; U.S. Department of the Interior Fish and Wildlife Service: Washington, DC
Software: SAS Institute, Inc. (1999). SAS/IML User's Guide, Version 8. Cary, NC: SAS Institute, Inc.
Illustrations. Once articles are accepted, illustrations must then be submitted (line drawings, halftones, photos, photomicrographs, etc.) as clean originals or digital files. Digital files are recommended for highest quality reproduction and should follow these guidelines:
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300 dpi or higher
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Sized to fit on journal page
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EPS, TIFF, or PSD format only
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Submitted as separate files, not embedded in text files
Color Reproduction. Color illustrations will be considered for publication; however, the author will be required to bear the full cost involved in color art reproduction. Color art can be purchased for online only conversion and reproduction or for print + online reproduction. Color reprints can only be ordered if print + online reproduction costs are paid. Rates for color art reproduction are:
Online Only Reproduction: $225 for the first page of color; $100 per page for each of the next three pages of color. A maximum charge of $525 applies.
Print + Online Reproduction: $900 for the first page of color; $450 per page for each of the next three pages of color. A custom quote will be provided for articles with more than 4 pages of color.
Tables and Figures. Tables and figures (illustrations) should not be embedded in the text, but should be included as separate sheets or files. A short descriptive title should appear above each table with a clear legend and any footnotes suitably identified below. All units must be included. Figures should be completely labeled, taking into account necessary size reduction. Captions should be typed, double-spaced, on a separate sheet. All original figures should be clearly marked in pencil on the reverse side with the number, author's name, and top edge indicated.
Proofs. Page proofs are sent to the designated author using Taylor & Francis' EProof system. They must be carefully checked and returned within 48 hours of receipt. Color proofs will be provided for art physically printing in color if author consent is received by the requested due date.
Reprints. Each corresponding author will receive a PDF file of the article via email. This file is for personal use only and may not be copied and disseminated in any form without the prior written permission of Taylor & Francis Group, LLC.
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