Author Guidelines

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Author Guidelines

General

Pharmaceutical Statistics is an industry-led initiative, tackling real problems in statistical applications. The Journal publishes papers that share experiences in the practical application of statistics within the pharmaceutical industry. It covers all aspects of pharmaceutical statistical applications from discovery, through pre-clinical development, clinical development, post-marketing surveillance, consumer health, production, epidemiology, and health economics.

The journal is both international and multidisciplinary. It includes high quality practical papers, case studies and review papers.

The aims of the Journal are to:

1. Disseminate information and practical examples of the full range of statistical methods and statistical thinking in all stages of drug development, from discovery to production;
2. Debate the current practice and application of statistics within the pharmaceutical industry and how this can best be developed;
3. Discuss and bring awareness to regulatory guidance documents;
4. Provide a vehicle for communication between practitioners, researchers, educators and policy makers concerned with the application of statistics within drug development; and
5. Provide guidance and tutorials to statisticians working within the pharmaceutical area.

Note to NIH Grantees. Pursuant to NIH mandate, Wiley will post the accepted version of contributions authored by NIH grant-holders to PubMedCentral upon acceptance. This accepted version will be made publicly available 12 months after publication. For further information, see NIH Mandate.

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Article Formats Published in PST

PST publishes research papers, short communications, case studies, book reviews, software reviews, viewpoint articles, and tutorial papers.

Main Papers (Original Articles) should be novel and share experiences in the practical application of statistics within the pharmaceutical industry. There is no formal limit on the word count. However, a lengthy manuscript might suggest that clarity of the presentation can be improved. If the word count exceeds 4,000 it is suggested to consider shortening or omitting selected sections.

Short Communications are short contributions that present original and significant material for rapid dissemination. Short Communications should not exceed 1,500 words.

Viewpoint articles are short pieces that express the opinions of the authors. The ideal length of a viewpoint is 1,000-1,500 words. Viewpoint articles should focus on a particular subject and should not contain great technical detail. Papers that rely on technical arguments to support the authors’ positions or opinions should be submitted as main papers. 

Tutorial papers (formerly Teacher's Corner papers) are intended for those involved in training or statistical education to share experience, training materials and ideas.

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Manuscript Submission

All papers must be submitted via the online system. Pharmaceutical Statistics operates an online submission and peer review system that allows authors to submit articles online and track their progress via a web interface. Please read the remainder of these instructions to authors and submit via the Research Exchange submission portal https://wiley.atyponrex.com/journal/PST. You may check the status of your submission at any time by logging on to submission.wiley.com and clicking the “My Submissions” button. For technical help with the submission system, please review our FAQs or contact [email protected].

IMPORTANT: Please check whether you already have an account in the system before trying to create a new one. If you have reviewed or authored for the journal in the past year it is likely that you will have had an account created.

Preprint Policy

Pharmaceutical Statistics will consider for review articles previously available as preprints. Authors may also post the submitted version of a manuscript to a preprint server at any time. Authors are requested to update any pre-publication versions with a link to the final published article.

Please find the Wiley preprint policy here.

File types. Preferred formats for the text and tables of your manuscript are .doc, .rtf, .ppt, .xls. LaTeX files may be submitted provided that a .pdf file is uploaded in addition to the source files. Figures may be provided in .tiff or .eps format. Pharmaceutical Statistics will not accept .pdfs as source files. Main document and Image files must be supplied in one of the preferred document formats.

Data Protection

By submitting a manuscript to or reviewing for this publication, your name, email address, and affiliation, and other contact details the publication might require, will be used for the regular operations of the publication, including, when necessary, sharing with the publisher (Wiley) and partners for production and publication. The publication and the publisher recognize the importance of protecting the personal information collected from users in the operation of these services, and have practices in place to ensure that steps are taken to maintain the security, integrity, and privacy of the personal data collected and processed. You can learn more at https://authorservices.wiley.com/statements/data-protection-policy.html.

Initial Submission

NON-LATEX USERS: Upload your manuscript files. At this stage, further source files do not need to be uploaded.

LATEX USERS: For reviewing purposes you should upload a single .pdf that you have generated from your source files. You must use the File Designation "Main Document" from the dropdown box.

Revised Submission

NON-LATEX USERS: Editable source files must be uploaded at this stage. Tables must be on separate pages after the reference list, and not be incorporated into the main text. Figures should be uploaded as separate figure files.

LATEX USERS: When submitting your revision you must still upload a single .pdf that you have generated from your now revised source files. You must use the File Designation "Main Document" from the dropdown box. In addition you must upload your TeX source files. For all your source files you must use the File Designation "Supplemental Material not for review". Previous versions of uploaded documents must be deleted. If your manuscript is accepted for publication we will use the files you upload to typeset your article within a totally digital workflow.

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Open Access

Open Access is available to authors of primary research articles who wish to make their article available to non-subscribers on publication, or whose funding agency requires grantees to archive the final version of their article. With Open Access, the author, the author's funding agency, or the author's institution pays a fee to ensure that the article is made available to non-subscribers upon publication via Wiley Online Library, as well as deposited in the funding agency's preferred archive. For the full list of terms and conditions, see here. For more information on this journal’s APCs, please see the Open Access page.

Any authors wishing to send their paper Open Access will be required to complete the payment form available from our website here.

Prior to acceptance there is no requirement to inform the Editorial Office that you intend to publish your paper Open Access if you do not wish to. All Open Access articles are treated in the same way as any other article. They go through the journal's standard peer-review process and will be accepted or rejected based on their own merit.

Copyright and Permissions

To enable the publisher to disseminate the author's work to the fullest extent, the author must sign a license agreement transferring copyright in the article from the author to the publisher, and complete the agreement with the article presented for publication. Submission of a manuscript will be held to imply that it contains original unpublished work and is not being submitted for publication elsewhere at the same time. Submitted material will not be returned to the author, unless specifically requested.

If your paper is accepted, the author identified as the formal corresponding author for the paper will receive an email prompting them to login into Author Services; where via the Wiley Author Licensing Service (WALS) they will be able to complete the license agreement on behalf of all authors on the paper.

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Article Preparation Support

Papers must be in English. Oxford English Dictionary or American spelling is acceptable, provided usage is consistent within the manuscript.

Manuscripts that are written in English that is ambiguous or incomprehensible, in the opinion of the Editor, will be returned to the authors with a request to resubmit once the language issues have been improved. This policy does not imply that all papers must be written in "perfect" English, whatever that may mean. Rather, the criterion will require that the intended meaning of the authors must be clearly understandable, i.e., not obscured by language problems, by referees who have agreed to review the paper.

Wiley Editing Services offers expert help with English Language Editing, as well as translation, manuscript formatting, figure illustration, figure formatting, and graphical abstract design – so you can submit your manuscript with confidence. Also, check out our resources for Preparing Your Article for general guidance about writing and preparing your manuscript.  

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Presentation of papers

Free Format submission

Pharmaceutical Statistics now offers Free Format submission for a simplified and streamlined submission process.
Before you submit, you will need:

  • Your manuscript: this should be an editable file including text, figures, and tables, or separate files – whichever you prefer. All required sections should be contained in your manuscript, including abstract (which does need to be correctly styled), introduction, methods, results, and conclusions. Figures and tables should have legends. Figures should be uploaded in the highest resolution possible. If the figures are not of sufficiently high quality your manuscript may be delayed. We also encourage you to include your figures within the main document to make it easier for editors and reviewers to read your manuscript. References may be submitted in any style or format, as long as it is consistent throughout the manuscript (PST's reference style is AMA - see below for further information). Supporting information should be submitted in separate files. If the manuscript, figures or tables are difficult for you to read, they will also be difficult for the editors and reviewers, and the editorial office will send it back to you for revision. Your manuscript may also be sent back to you for revision if the quality of English language is poor.
  • An ORCID ID, freely available at https://orcid.org. (Why is this important? Your article, if accepted and published, will be attached to your ORCID profile. Institutions and funders are increasingly requiring authors to have ORCID IDs.
  • The title page of the manuscript, including:
o Your co-author details, including affiliation and email address. (Why is this important? We need to keep all co-authors informed of the outcome of the peer review process.)
o Statements relating to our ethics and integrity policies, which may include any of the following (Why are these important? We need to uphold rigorous ethical standards for the research we consider for publication):
      • data availability statement
      • funding statement
      • conflict of interest disclosure
      • ethics approval statement
      • patient consent statement
      • permission to reproduce material from other sources
      • clinical trial registration
To submit, login at https://wiley.atyponrex.com/journal/PST and create a new submission. Follow the submission steps as required and submit the manuscript.

Manuscript style
  • During the submission process you must enter
    1) the full title
    2) names and affiliations of all authors and
    3) the full address, including email, telephone and fax of the author who is to check the proofs.

  • Include the name(s) of any sponsor(s) of the research contained in the paper, along with grant number(s).

  • Enter an abstract of no more than 250 words for all articles. Please see the guidance below on acceptable abstract writing for PST.

  • Keywords. Authors should prepare no more than 6 keywords for their manuscript.

  • Appendices. Any additional material which is not essential to the article, data and tables should be submitted as an online-only Appendix. Please upload the Appendix as “Supplementary material not for review” on the online system.

Search Engine Optimization for Your Paper

Consult our SEO Tips for Authors page in order to maximize online discoverability for your published research. Included are tips for making your title and abstract SEO-friendly, choosing appropriate keywords, and promoting your research through social media.

Article Promotion Support

Wiley Editing Services offers professional video, design, and writing services to create shareable video abstracts, infographics, conference posters, lay summaries, and research news stories for your research – so you can help your research get the attention it deserves.

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Writing Abstracts

An abstract is a concise summary of the whole paper, not just the conclusions. The abstract should be no more than 250 words and convey the following:

1. An introduction to the work. This should be accessible by scientists in any field and express the necessity of the experiments executed
2. Some scientific detail regarding the background to the problem
3. A summary of the main result
4. The implications of the result
5. A broader perspective of the results, once again understandable across scientific disciplines

It is crucial that the abstract conveys the importance and novelty of the work and be understandable without reference to the rest of the manuscript to a multidisciplinary audience. Abstracts should not contain any citation to other published works.

Reference Style

AMA Reference style

References: All references should be numbered consecutively in order of appearance and should be as complete as possible. In text citations should cite references in consecutive order using Arabic superscript numerals. Sample references follow:

Journal article:

1. King VM, Armstrong DM, Apps R, Trott JR. Numerical aspects of pontine, lateral reticular, and inferior olivary projections to two paravermal cortical zones of the cat cerebellum. J Comp Neurol 1998; 390: 537-551.

Book:

2. Voet D, Voet JG. Biochemistry. New York: John Wiley & Sons; 1990. 1223 p.

Please note that journal title abbreviations should conform to the practices of Chemical Abstracts. For more information about AMA reference style - AMA Manual of Style

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Citing Early View Articles

To include the DOI* in a citation to an article, simply append it to the reference as in the following example:

Weaver PJ, Laures AM-F, Wolff J-C. Investigation of the advanced functionalities of a hybrid quadrupole orthogonal acceleration time-of-flight mass spectrometer. Rapid Commun Mass Spectrom 2007: DOI: 10.1002/RCM.21464.

To link to an article from the author’s homepage, take the DOI (digital object identifier) and append it to "http://dx.doi.org/" as per following example:

DOI:10.1002/pst.20941, becomes http://dx.doi.org/10.1002/pst.20941.

*The Digital Object Identifier (DOI) is an identification system for intellectual property in the digital environment. Developed by the International DOI Foundation on behalf of the publishing industry, its goals are to provide a framework for managing intellectual content, link customers with publishers, facilitate electronic commerce, and enable automated copyright management.

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Illustrations

Upload each figure as a separate file in either .tiff or .eps format, with the figure number and the top of the figure indicated. Compound figures e.g. 1a, b, c should be uploaded as one figure. Tints are not acceptable. Lettering must be of a reasonable size that would still be clearly legible upon reduction, and consistent within each figure and set of figures. Where a key to symbols is required, please include this in the artwork itself, not in the figure legend. All illustrations must be supplied at the correct resolution:

  • Black and white and colour photos - 300 dpi
  • Graphs, drawings, etc - 800 dpi preferred; 600 dpi minimum
  • Combinations of photos and drawings (black and white and colour) - 500 dpi

Tables should be part of the the main document and should be placed after the references. If the table is created in excel the file should be uploaded separately. Illustrations will be reproduced in colour. 

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Guidelines for Cover Submissions

If you would like to send suggestions for artwork related to your manuscript to be considered to appear on the cover of the journal, please follow these general guidelines.

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Supporting Information

Supporting Information can be a useful way for an author to include important but ancillary information with the online version of an article. Examples of Supporting Information include additional tables, data sets, figures, movie files, audio clips, 3D structures, and other related nonessential multimedia files. Supporting Information should be cited within the article text, and a descriptive legend should be included. It is published as supplied by the author, and a proof is not made available prior to publication; for these reasons, authors should provide any Supporting Information in the desired final format.

For further information on recommended file types and requirements for submission, please visit: http://authorservices.wiley.com/bauthor/suppinfo.asp

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Data Policy

PST expects that data supporting the results in the paper will be archived in an appropriate public repository. Whenever possible the scripts and other artefacts used to generate the analyses presented in the paper should also be publically archived. Exceptions may be granted at the discretion of the editor for sensitive information such as human subject data or the location of endangered species. Authors are expected to provide a data accessibility statement, including a link to the repository they have used, to accompany their paper.

Visit re3data.org or fairsharing.org to help identify registered and certified data repositories relevant to your subject area.

Wiley journals require data to be cited in the same way as article, book, and web citations and authors are required to include data citations as part of their reference list.

More information about the Data Sharing Policy can be found here. For information about Wiley's Data Citation Policy, click here.

Authors are strongly encouraged to submit computer code and data sets used to illustrate new methods.

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Lay Abstracts

For accepted manuscripts, if you feel that your article will have broad appeal beyond the readership of Pharmaceutical Statistics, you may wish to consider providing a “lay abstract” to appear on Wiley’s statistics community website, Stats & Data Science Views. The site attracts approximately 10,000 visitors a month and has a substantial social media following on Twitter. A large proportion of visitors are students who find lay abstracts of articles very useful in their education.

This abstract or commentary should be written in the third person, be substantially less technical than the formal abstract, and be at least 200 words. It should explain the importance of your work in a broader context, appealing to a non-specialist statistical audience. We may use this information to highlight your research on Stats & Data Science Views and our social media networks. When ready, you may email your lay abstract to Stephen Raywood ([email protected]).

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Publication Ethics

Wiley's Best Practice Guidelines on Publishing Ethics are now available. The aim for these guidelines remains to support all those involved in scholarly publishing with a summary of best practice guidance from leading organizations around the world. Our guidelines are written for societies, editors, authors, librarians, students, funders, corporations, and journalists.

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Author Name Change Policy

In cases where authors wish to change their name following publication, Wiley will update and republish the paper and redeliver the updated metadata to indexing services. Our editorial and production teams will use discretion in recognizing that name changes may be of a sensitive and private nature for various reasons including (but not limited to) alignment with gender identity, or as a result of marriage, divorce, or religious conversion. Accordingly, to protect the author’s privacy, we will not publish a correction notice to the paper, and we will not notify co-authors of the change. Authors should contact the journal’s Editorial Office with their name change request.

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Further Information

For accepted manuscripts the publisher will supply proofs to the submitting author prior to publication. This stage is to be used only to correct errors that may have been introduced during the production process. Prompt return of the corrected proofs, preferably within two days of receipt, will minimise the risk of the paper being held over to a later issue.

Free access to the final PDF offprint or your article will be available via Author Services only. Please therefore sign up for Author Services if you would like to access your article PDF offprint and enjoy the many other benefits the service offers. There is no page charge to authors.

To purchase reprints in smaller quantities, please visit http://olabout.wiley.com/WileyCDA/Section/id-404512.html. Restrictions apply to the use of reprints – if you have a specific query, please contact [email protected]. Corresponding authors are invited to inform their co-authors of the reprint options available

Manuscript accepted for publication? If so, check out our suite of tools and services for authors and sign up for:
• Article Tracking
• E-mail Publication Alerts
• Personalization Tools

Potential threat to security

Where a reviewer is concerned that an article might include information that could be a threat to security then the Editor will treat the article as possible DURC (dual use research of concern) and may consult a specialist reviewer.  Their advice will be taken into account by the Editor in making any final decision on publication.

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