The Journal of Clinical Pharmacology

Cover image for Vol. 56 Issue 6

Edited By: Joseph S. Bertino, Jr., Schenectady, NY

Impact Factor: 2.475

ISI Journal Citation Reports © Ranking: 2014: 117/254 (Pharmacology & Pharmacy)

Online ISSN: 1552-4604

Associated Title(s): Clinical Pharmacology in Drug Development



Author Guidelines


INSTRUCTIONS FOR AUTHORS: Please visit The Journal of Clinical Pharmacology at http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1552-4604/homepage/ForAuthors.html to reach these instructions at any time.

For guidance on how to prepare, write and submit a manuscript to any journal, please follow this link: http://www.mpip-initiative.org/mpip-authorship-activities/authors-submission-toolkit

Page Charges: JCP has no page charges for publication.

Please Note: These instructions must be followed for manuscript submission to JCP. Manuscripts will be returned without review if the instructions are not followed.

EDITORIAL CONTENT:


JCP is a publication dedicated to clinical (human) pharmacology. Manuscripts are invited that deal with the effects of drugs in humans. Animal research and in vitro research without direct human applicability will not be considered. These include, but are not limited to, the general categories of pharmacokinetics (PK) and drug disposition, drug metabolism, pharmacodynamics (PD), clinical trials and design issues, pharmacogenomics and pharmacogenetics, pharmacometrics and population PK/PD, pharmacoepidemiology, pharmacovigilence, and human pharmacology. In addition, another area of emphasis for submissions is the validation and use of biomarkers in drug development. Articles should be clearly written and well organized. Priority will be given to new developments in the field along with manuscripts dealing with PK/PD relationships of drug response in humans.

TYPES OF PAPERS (The limits should be strictly followed):

Original Research Papers (Full Manuscript): These may be up to 6500 words, 8 tables/figures total and up to 150 references. An unstructured abstract is required.

Original Research Papers (Brief Report): These may be up to 3250 words, 4 tables/figures total and up to 75 references. An abstract is not required.

Reviews: These may be up to 7000 words, 10 tables/figures total and up to 200 references. An unstructured abstract is required.

Reporting on Meta-Analyses: All meta-analyses to be published in the Journal should have clear objectives regarding drug effects and be based on thorough, systematic and recent review of the literature. Usually, a meta-analysis is done to determine the general and more specific effects on the basis of various small or large studies investigating the same research questions. The search strategy, selection process and statistical methods used should be described in detail in the manuscript. Beyond the type and design of selected studies, authors should provide details on exposure regarding the drug(s) to be examined, i.e., substance, dose, route of administration, and duration of treatment. Relevant patient characteristics, e.g.,. demographics, disease state and co-medication, should be described in sufficient detail. Meta-analysis of clinical trials should be accompanied by the PRISMA flow diagram and checklist (LIberati et al., PLoS Med. 2009 Jul 21;6(7):e1000100), those of observational studies of clinical trials should be accompanied by the MOOSE checklist (Stroup et al., JAMA. 2000; 283(15):2008-12). The preferred length of meta-analyses is as described above for original research papers. Extensive tables on the characteristics of included or excluded studies should be submitted as Electronic Supplementary Material (ESM) (for detailed information on ESM see also Electronic Supplementary Material in the Instructions for Authors) and will be published online only. Meta-analyses reports should follow the guidelines for Full Manuscript Original Research Papers.

Commentaries: These are invited or unsolicited to give a scientific opinion on a topic pertinent to clinical pharmacology or to comment on an article that will appear in the same issue of the Journal. Commentaries do not required an abstract. The suggested length is 1500 words with no more than 15 references.

Case Series and Review: JCP will accept for review case report series that includes at least THREE cases. Single case reports will not be sent for review. The Editor-in-Chief may suggest to an author that limited case reports be submitted as a Letter to the Editor. An abstract is not required for Case Series and Review.

Letters to the Editor: Letters for consideration should address articles previously published in JCP or issues felt to be of importance to JCP readers. Letters must be 500 words or less and no abstract is required.

Book Reviews: Summaries should be limited to approximately 250 words. Publishers should send inquiries regarding books for possible review to the editorial office for consideration.

Sponsored Supplements: Issue supplements are occasionally published, and the costs are borne by outside sponsors. Contents must undergo peer review, and final approval rests with the Editor. More information can be obtained by contacting the editorial office.

GENERAL MANUSCRIPT STYLE AND SUBMISSION GUIDELINES:

Please follow the AMA Manual of Style: A Guide for Authors and Editors, 10th edition, 2007. This guide provides specifics for style, data analysis and presentation and terminology to be used. Additionally, these guidelines outline authorship criteria for manuscripts.

We require that manuscripts submitted to JCP be reviewed for grammar and spelling by a native speaker of English or preferably an English language editing service for our non-English speaking authors before submission.

English Style:
Please use Western English. If British English spelling is used, the manuscript will be returned to the authors for correction before consideration is given for review.

Manuscripts not following these general manuscript style guidelines will be returned without review.

Cover letter:
For initial submission of a manuscript, a cover letter detailing originality of the manuscript and agreement of all authors and also identifying the Principal Investigator who undertook any human studies reported is required.

Disclosures:
Authors must disclose all financial involvements (including stock ownership or options that are unrelated to primary employment, consultancies, honoraria, research grants, and royalties) connected with the work or its sponsors, as well as all sources of support, including government and industry support.   Also please disclose any competing or conflicts of interest and state if you used the assistance of a professional medical writing company for your manuscript preparation. Please provide the name of the company. Disclosure information will be published with accepted manuscripts as Acknowledgements. If there are no disclosures, please state that as well (Note: You will be asked these questions during the submission process on ScholarOne, and the information should match what is on your title page.).

Plagiarism Screen:
All manuscripts submitted are screened using the software iThenticate which is a web-crawling software that can compare the current manuscript with multiple published sources.

Authorship:
Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.

Authorship on a manuscript should follow the 2013 ICMJE and GPP3 guidelines as noted below.

Corresponding Author:
One author should be designated as the corresponding author to correspond with the editorial staff, receive galley proofs, and handle reprint requests. That author's primary affiliation, complete mailing address, telephone numbers, fax number, and e-mail address should be included.

Manuscript Text:
Text Formatting

Manuscripts should be submitted in Word.

Use a normal, plain font (e.g., 12point Times Roman) for text. Use italics for emphasis.

Use the automatic page numbering function to number the pages. Do not use field functions.

Use tab stops or other commands for indents, not the space bar. Use the table function, not spreadsheets, to make tables.

Use the equation editor or MathType for equations.

Save your file in docx format (Word 2007 or higher) or doc format (older Word versions).

MANUSCRIPT FORMAT AND FLOW:

Tables and Figures: Please do not put placeholders in the manuscript for tables and figures.

TITLE PAGE:

Please include the following on the first page of your submitted manuscript:

- Title
- Full names, with terminal degrees listed, and affiliations of all authors
- Name and address of corresponding author
- Indicate which authors, if any, are Fellows of the American College of Clinical Pharmacology (FCP)
- Any disclosures (financial, conflicts of interest, and use of a professional medical writing company)
- Word count for the body of the manuscript, the aggregate number of figures and tables, and the number of References

Abstract:
Please provide an unstructured abstract of up to 250 words for Full Reports, Meta-Analyses and Reviews only. Other types of manuscripts do not need an abstract.

Keywords:
Please provide 4 to 6 keywords, which can be used for indexing purposes.

Headings:
Please do not enumerate or place letters before headings or subheadings. Headings should be as follows:

- Introduction
- Methods
- Results
- Discussion
- Conclusions

INTRODUCTION:

This should be short with the majority of information in the Discussion section.

METHODS:


Methodology is the most important section of a manuscript as it determines if the results and conclusions of the study were validly derived. Methods should be concise and clear such that the study could be reproduced by another investigator. Please read carefully the requirements for Methods.

Human subject protection:
In the first sentence of the Methods section it must be explicitly stated that an investigational review board (IRB) or human subjects committee approved the study protocol, and the specific IRB should be named first in the “Methods” section. Additionally, the informed consent statement must be placed in this section right after the IRB information. For studies with large numbers of sites, such as population pharmacokinetic studies, the Editor may at his discretion append the specific sites in an online version because of space considerations. In those cases, a notation to that effect will be included in the “Methods” section of the paper.

Drug nomenclature:
All drugs and therapeutic agents must be referred to by their accepted generic or chemical name. The name should not be abbreviated. Code numbers should be used only when a generic name is not yet available. In that case, the chemical name and a figure giving the chemical structure of the drug are required. A proprietary/trade name may be used one time in the “Methods” section of a report to designate a particular preparation used in a study. In Editorials or Commentaries, the Editor may elect to allow 1 parenthetical use of a trade name following the first mention of the generic name, if this is felt to be scientifically pertinent and not promotional.

Laboratory results:
Laboratory values must be expressed in U.S. Conventional Units with normal ranges for the laboratory in use supplied. SI units may be reported IN ADDITION to U.S. Conventional Units with the same caveats as noted here.

Pharmacokinetic Terminology:
Please refer to the following link for pharmacokinetic terminology to use for JCP:

http://onlinelibrary.wiley.com/store/10.1111/(ISSN)1365-2125/asset/homepages/BJCP_PK_and_other_symbols.pdf?v=1&s=e147e5ed5d667b1e57c9c7353c7b153413105529&isAguDoi=false

Other Abbreviations and Standard Terminology:
Standard, accepted abbreviations and terminology should be used in the manuscript. Abbreviations that are developed to save word space are not acceptable (abbreviations developed for example such as: glucagon releasing muscle building factor or GRMBF) cannot be used unless they are standard accepted abbreviations in the medical literature. Manuscripts with excessive abbreviations will be returned to the author for correction. In addition, changing standard terminology (i.e., drug phenotyping cocktails being referred to as drug phenotyping cassettes) is not acceptable and results in confusion to the reader.

Requirements for Referencing Analytic Methods in Original Reports:
Analytic methods that are not referenced to archived peer-reviewed publications must include specific core information, such as the detector and monitoring settings, internal standards, and assay performance parameters. Specific sample preparation details are not required, but a general synopsis is requested. Assays listed as "proprietary information" are not acceptable.

Requirements for Data Analysis:
Statistical, pharmacokinetic, pharmacodynamic, pharmacometric or other types of analysis must be performed using validated programs that are available to other investigators either free of charge or for a fee to acquire from the developer. The specific program(s) used must be specified in the manuscript.

RESULTS:


All data should be expressed as ONE significant figure (following AMA guidelines) unless there are “special” circumstances or otherwise accepted convention.

Statistical results should be expressed as significant (p?0.05) or not significant (p>0.05).

Terminology such as “trends to significance” or the like should not be used if the p value does not reach the 0.05 level.

Equivalence tests are not significance tests and thus the term "significant or not significant" should not be used to describe the results of these tests.

Table and Figure Preparation:
Figures and tables should be numbered in the order in which they are discussed in the text. Data should be expressed to ONE significant figure. The aggregate total for original articles must not exceed eight items (see the limits for other types of article above). Excess illustrations may be provided as a supplementary file for electronic access only (see the next section). Figures submitted in color will be published in color in the online journal at no charge to authors. Any color used in figures should be in contrasting shades to avoid grayed out images, and mention of specific colors in figure captions should be avoided. Each figure and table must be able to “stand on its own,” that is be interpreted without reading the entire manuscript.

- Tables and figures should not be embedded into the text of the manuscript
- All tables/figures are to be numbered using Arabic numbers
- Tables/figures must be cited in the text in numerical order
- All abbreviations used in each table/figure must be defined in each table/figure
- Tables/figures from other publication should be referenced with the corresponding number of the reference in the reference list and not within a reference citation.

DISCUSSION AND CONCLUSION:

Each manuscript should have a discussion of the pertinent results with a review and interpretation of appropriate literature along with a brief conclusion.

SUPPLEMENTARY ONLINE MATERIAL:

Excess illustrations or other materials may be provided to publish online only. Because supplementary material is not copyedited or typeset, it should be submitted exactly as it is to be viewed. List article title and authors (or lead author) at the top of the page, and include captions for any tables and figures. Supplementary tables and figures should be numbered beginning with an "S" (Supplemental Table S1) to distinguish them from regular tables/figures; references to supplemental materials within the main article should also follow this numbering system. Please see our full guidelines for Supporting Information at http://authorservices.wiley.com/bauthor/suppinfo.asp

REFERENCES:

Notation within the text should be in sequential numeric superscript. References should appear at the end of the manuscript using the format of the American Medical Association Manual of Style (10th edition) and should contain all authors of the original report unless there are ore than 6 authors, in which case the first 3 authors should be listed, followed by "et al."

MANUSCRIPT SUBMISSION:


All manuscripts must be submitted online to JCP through ScholarOne Manuscripts, as follows:

Accessing ScholarOne Manuscripts:
Go to http://mc.manuscriptcentral.com/jocp. Please see “User Tutorial for Authors” for complete instructions on creating an account and submitting a manuscript. For further assistance, e-mail Elizabeth Marshall, Assistant Managing Editor, elizabeth.marshall@kwfco.com.

Uploading your article: The manuscript should be submitted in Microsoft Word format. Tables and figures, in separate files, should follow the manuscript file submission. Each table should be in Word or Excel format and include a title and appropriate footnotes. Figure legends should be included in a separate Word file sequenced before the figure files.

Figures must have 1/4 inch margins on all sides to allow for line and page numbering added to the PDF review proof. They should be provided as TIFF, EPS, PNG or less preferably, PPT or PDF files. Please note: Often the copy and paste function into a PDF results in a figure that is not sharp for final copy. Please examine your PDFs before uploading and when in doubt, please use the TIFF, EPS, or PNG format to upload figures so that they are sharp. Additionally, the allowed file size for figures is 40 megapixels and 350 MB. Larger size files will give an error message and you will not be able to upload those files. Please do not submit artwork in Microsoft Office applications (Word, PowerPoint, Excel) and do not embed figures and tables in the manuscript. All figures should be at least 300 dpi at final size. Please see our full guidelines for artwork at http://authorservices.wiley.com/bauthor/illustration.asp

ETHICAL RESPONSIBILITIES OF AUTHORS:

The Journal of Clinical Pharmacology is committed to upholding the integrity of the scientific record. Authors should refrain from misrepresenting research results which could damage the trust in the Journal, the professionalism of scientific authorship, and ultimately the entire scientific endeavor.

Changes of authorship or in the order of authors are not accepted after acceptance of a manuscript. Requesting to add or delete authors at revision stage, proof stage, or after publication is a serious matter and may be considered when justifiably warranted. Justification for changes in authorship must be compelling and may be considered only after receipt of written approval from all authors and a convincing, detailed explanation about the role/deletion of the new/deleted author. In case of changes at revision stage, a letter must accompany the revised manuscript. In case of changes at after acceptance or publication, the request and documentation must be sent to the Editor-in-Chief. In all cases, further documentation may be required to support the request. The decision on accepting the change rests with the Editor-in-Chief of the Journal and may be turned down. Therefore authors are strongly advised to ensure the correct author group, corresponding author, and order of authors at submission.

PEER-REVIEW PROCESS:

Initial review: If a manuscript is selected for review, it will be sent to at least 2 reviewers. A decision will then be sent to the author, generally within 4 weeks. The JCP review system is not blinded. The Editor will recuse himself from all proceedings involving manuscripts in which there is a conflict of interest for him, and the resulting process for those manuscripts will be blinded from the Editor. All attempts are made to identify potential conflicts of interest before reviewer assignment; however, reviewers should excuse themselves if an assignment with a conflict of interest is made.

Revised manuscripts: Revised manuscripts must also be submitted through ScholarOne Manuscripts. In the resubmission, authors must include a cover letter as well as explicit responses to reviewers’ comments in the rebuttal box in ScholarOne Manuscripts and two versions of the revision: one clean and one showing track changes or with changes highlighted. Revised manuscripts must be submitted within 30 days unless explicit permission for an extension is obtained from the editorial office. Other manuscripts are subject to withdrawal from the system.

Permissions: Direct quotations, tables, or illustrations that have appeared in copyrighted material must be accompanied by written permission for their use from the copyright owner (usually the publisher) and original author, along with complete information as to the source. Any photographs of identifiable persons should be accompanied by signed releases that show informed consent. The author is responsible for obtaining all permissions.

Requests for permission to reproduce material that has appeared in JCP should be submitted online via Wiley Online Library, www.wileyonlinelibrary.com.

MANUSCRIPT ACCEPTANCE:

Once accepted, the manuscript will be published using a PDF version of the author’s final Word file on the JCP website in the "Accepted Articles" section. Authors will receive an email with instructions as to how to download and make corrections and answer queries on their proof. Once the copy proof is reviewed and finalized by the Editor, the article will appear on the JCP website in the “Early View” section and removed from the "Accepted Article" section of the JCP website.

Proofing the manuscript: The purpose of the proof is to check for typesetting or conversion errors and the completeness and accuracy of the text, tables and figures. Substantial changes in content, e.g., new results, corrected values, title and authorship, are not allowed without the approval of the Editor. After online publication, further changes can only be made in the form of an Erratum, which will be hyperlinked to the article.

Copyright: If the manuscript 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.

For Authors Signing the Copyright Transfer Agreement:
If the OnlineOpen option is not selected the corresponding author will be presented with the copyright transfer agreement (CTA) to sign. The terms and conditions of the CTA can be previewed in the samples associated with the Copyright FAQs below: CTA Terms and Conditions http://authorservices.wiley.com/bauthor/faqs_copyright.asp.

For Authors Choosing OnlineOpen:
If the OnlineOpen option is selected the corresponding author will have a choice of the following Creative Commons License Open Access Agreements (OAA): Creative Commons Attribution Non-Commercial License OAA Creative Commons Attribution Non-Commercial-NoDerivs License OAA

To preview the terms and conditions of these open access agreements please visit the Copyright FAQs hosted on Wiley Author Services (http://authorservices.wiley.com/bauthor/faqs_copyright.asp) and visit http://www.wileyopenaccess.com/details/content/12f25db4c87/Copyright--License.html.

If you select the OnlineOpen option and your research is funded by The Well come Trust and members of the Research Councils UK (RCUK) you will be given the opportunity to publish your article under a CC-BY license supporting you in complying with Well come Trust and Research Councils UK requirements. For more information on this policy and the Journal’s compliant self-archiving policy please visit: http://www.wiley.com/go/funderstatement.

For RCUK and Well come Trust authors click on the link below to preview the terms and conditions of this license: Creative Commons Attribution License OAA To preview the terms and conditions of these open access agreements please visit the Copyright FAQs hosted on Wiley Author Services (http://authorservices.wiley.com/bauthor/faqs_copyright.asp) and visit http://www.wileyopenaccess.com/details/content/12f25db4c87/Copyright--License.html.

Announcements: JCP will publish official notices of interest to the members of the American College of Clinical Pharmacology.

Reprints: Authors will receive a schedule of reprint costs with galley proofs. More information regarding reprints can be obtained from Dave Surdel, Reprint Sales Director, Wiley-Blackwell, 350 Main Street, Malden, MA 02148; phone: 781-388-8343; e-mail: dsurdel@wiley.com (mailto:dsurdel@wiley.com)

Inquiries: All inquiries regarding manuscripts that have not yet been published should be submitted by e-mail to Elizabeth Marshall, Assistant Managing Editor, at the following address: elizabeth.marshall@kwfco.com

Office Address:
The Journal of Clinical Pharmacology
605 Worcester Rd
Towson, MD 21286-7834

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