Author Guidelines


Information for Authors

Please visit Clinical Pharmacology in Drug Development at www.wileyonlinelibrary.com, and click on “Author Guidelines” to reach these instructions at any time.

Rationale

In the course of drug development, many clinical pharmacology studies are performed for candidate drugs. Each of these studies, including those with negative, contributes to the knowledge base about a new therapeutic agent. However, many such studies are not individually published, and the knowledge derived from them may become available, if at all, only in aggregate form in the product label. Nonetheless, these studies contain important information of therapeutic relevance. In addition, the pharmaceutical industry is faced with increasing mandates to publish clinical study results secondary to their registration in the clinical trial data base. Clinical Pharmacology in Drug Development is a scientific journal intended to meet these needs.

Scope

Clinical Pharmacology in Drug Development (CPDD) is an international, peer-reviewed, online publication focused on publishing high-quality clinical pharmacology studies in drug development which are primarily (but not exclusively) performed in healthy volunteers during the early stages of the drug development process.

Acceptance of a manuscript in CPDD will be determined by scientific merit and technical soundness rather than perceived novelty of the outcome. Negative study results are explicitly not an obstacle for favorable acceptance decisions.

Suitable topics for submission include, but are not limited to:

  • First-time-in-human studies, including ascending single- and multiple-dose studies
  • Drug-drug interaction studies
  • Transporter interaction studies
  • Bioavailability and formulation effect studies
  • Food/beverage effect studies
  • In vitro drug-drug interaction studies using human tissues
  • Mass balance studies
  • Comparability studies for biosimilars
  • Bioequivalence studies, including those required for generic drug approval
  • Standard population pharmacokinetic analyses
  • Clinical trials focused on clinical pharmacology topics
  • Drug Effects on cardiac conduction (QT-interval studies)
  • Pharmacokinetic—pharmacodynamic studies
  • Epidemiologic studies of drug effects and adverse drug reactions

Manuscripts submitted to CPDD will undergo a rigorous peer review process.

CPDD is published online only. Paper or electronic reprints of individual articles are available for purchase on request. Six issues per year are published.

The majority of papers appearing in CPDD will represent reports of original research. CPDD will also consider and publish scholarly reviews, commentaries, and manuscripts on educational topics; these may be invited by the Editor, or be submitted without invitation. CPDD is owned by the American College of Clinical Pharmacology and is published by Wiley.


General Guidelines for Manuscript Preparation

CPDD is committed to a review and publication process that is as expeditious as possible. To that end, we are providing specific guidelines for manuscript preparation intended to streamline and accelerate the process.

Page Charges

To recover a portion of the publication costs, CPDD instituted a publication page charge for manuscripts submitted on or after October 1, 2013, and accepted for publication. The cost will be US $200.00 per printed page. This applies to all papers including those paying the OnlineOpen fee. Authors of accepted papers will receive a page charge form along with the initial proofs. The proofs represent the final number of printed pages, so that the cost will be evident. The process of editorial review of papers submitted to CPDD is not connected to the page charges.

Title

The title should factually state the topic of the research that was done, as opposed to interpreting the outcome. “Pharmacokinetic drug interaction stud of midazolam and acetaminophen,” or “Effect of acetaminophen on midazolam clearance” are suitable titles. “No clinically important effect of acetaminophen on midazolam clearance” is not a suitable title.

Abstract

Two hundred words or less. Topic headings or categories are not required.

Introduction

The Introduction should contain a brief summary of the candidate drug and its intended therapeutic application, but without language that could be considered promotional in nature. The rationale for doing the study should be clearly stated. For a drug-drug interaction (DDI) study, it may be that in vitro studies yielded a “signal” that acetaminophen might impair CYP3A activity, thereby requiring a clinical acetaminophen-midazolam DDI study. Alternatively, acetaminophen may be co-prescribed with CYP3A substrate drugs so frequently that a clinical DDI study is needed for safety assurance.

Subjects and Methods

Review and Informed Consent

All human research studies submitted to and published by CPDD must be compliant with the principles expressed in the Declaration of Helsinki.

The authors must state in the Methods section, ideally under the sub-heading Study Design, that the locally appointed ethics committee/institutional review board (IRB) has approved the research protocol, and that written informed consent was obtained from all subjects (or their guardian/s) prior to initiation of the study. The specific study site(s) and applicable IRB(s) should be explicitly named. For studies with multiple sites, such as population pharmacokinetic studies, the Editor may at his discretion append the specific sites in a supplementary online file due to space considerations. In those cases, a notation to that effect will be included in the “Methods” section of the paper.

Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in articles unless it is essential for scientific purposes and the patient (or their guardian/s) has given written informed consent for publication, which requires that the patient be shown the manuscript to be published. Identifying details should be omitted if they are not essential, but patient data should not be modified in an attempt to attain anonymity.

If reporting animal experimentation, authors should indicate which institutional/national guidelines or law on the care and use of laboratory animals was followed. Authors should consider relevant published ethical standards such as "Guidelines for the welfare and use of animals in cancer research"; (Workman, Aboagye, Balkwill et al. Br J Cancer 2010; 102: 1555-1577) and reporting standards such as the ARRIVE Guidelines (http://www.nc3rs.org.uk/arrive-guidelines).

The number and demographic characteristics of study participants are stated in the Methods section. Excessively detailed inclusion and exclusion criteria are not needed.

The study design can be provided in the text or in the form of a diagram.

A complete description of the analytic assay methods is essential, unless the assay procedure has been previously published. Required items are: internal standard(s), method of extraction, HPLC column and mobile phase, MS instrument settings, m/z monitored, within- and between-day variability, limits of sensitivity. It is not sufficient to state only that a validated method was used. Further explanation of these requirements can be found in the October 2012 issue of CPDD, pages 119-120.

For pharmacokinetic procedures, it is sufficient to state that standard noncompartmental methods were used.

Results

The Results section should be a factual description of the outcome. For DDI or bioequivalence studies, aggregated values of principal pharmacokinetic parameters should be presented in tabular form as arithmetic mean and standard error or standard deviation. The exception is the time of maximum concentration (Tmax), which is presented as median and range. The table can also present geometric means in addition to the arithmetic means. Comparison of treatment groups can proceed based on regulatory guidelines. For orally-administered drugs, it is not necessary to present volume of distribution terms or residence times.

Figures of mean plasma concentrations may be presented, along with standard error bars at each point. In preparing these figures, authors should treat values that are BLQ (below the limits of quantitation) as zero, and include those zero values in calculating the mean.

The Results should include an explanation of subject dropouts, and a brief description of adverse events, with a focus on unexpected or serious events. Terms such as “well-tolerated” should be avoided, since the general clinical applicability of data from single-dose studies in healthy volunteers is uncertain.

Discussion

The Discussion section should be factual rather than speculative. Authors should be conservative in the interpretation of the clinical importance of the outcome. If a DDI study result falls outside the default regulatory limits (90% confidence interval boundary above 1.25 or below 0.80), authors cannot state that the interaction is clinically unimportant unless there is independent concentration-response data for the candidate drug indicating that the change in exposure to the victim drug is not clinically significant.

Promotional language should not be used in the Discussion.


Manuscript Submission Process

All manuscripts must be submitted online to Clinical Pharmacology in Drug Development (CPDD) through ScholarOne Manuscripts, as follows:

Accessing ScholarOne Manuscripts

Go to http://mc.manuscriptcentral.com/cpd. 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. Tables and figures, in separate files, should follow the manuscript file. Each table should include a title and appropriate footnotes. Figure legends should be included in a separate file sequenced before the figure files. Figures should be provided as TIFF, EPS, or PDF files. Save line art such as charts, graphs and illustrations in EPS or PDF format; save photographic images in TIFF format. Please do not submit artwork in Microsoft Office applications (Word, Powerpoint, Excel) and do not embed figures in the manuscript. All figures should be at least 300 dpi at final size. Please see our full guidelines for artwork at https://authorservices.wiley.com/asset/photos/electronic_artwork_guidelines.pdf.

Declaration of Conflict of Interest and Financial disclosure

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. All information should appear on the title page of the submitted manuscript and match the information provided in the Declaration of Conflicting Interests and Financial Disclosure. The disclosure information will be published with accepted manuscripts as Acknowledgements. If there are no disclosures, that information will be stated as well. Some disclosures may be condensed for space reasons, but all original disclosures are available.

Copyright

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.

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 https://authorservices.wiley.com/author-resources/Journal-Authors/licensing-open-access/licensing/licensing-info-faqs.html

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 https://authorservices.wiley.com/author-resources/Journal-Authors/licensing-open-access/licensing/licensing-info-faqs.html 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 Wellcome 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 Wellcome 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 Wellcome 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 https://authorservices.wiley.com/author-resources/Journal-Authors/licensing-open-access/licensing/licensing-info-faqs.html and visit http://www.wileyopenaccess.com/details/content/12f25db4c87/Copyright--License.html.

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.

Cover letter

In a letter, describe the submission, the category in which it belongs, and its contribution to the medical literature.

Title page

Manuscript authors are listed without academic degrees. Include the name and address of the corresponding author, the address for reprints, and an indication of which authors, if any, are Fellows of the American College of Clinical Pharmacology (FCP). The primary affiliations of all authors must be listed, as should any financial interest disclosures. Please provide 3 to 5 keywords on the title page.

Abstract

All research manuscripts must include an abstract (without structured headings) of 200 words or less.

Table and figure preparation

Figures and tables should be numbered in the order in which they are discussed in the text. Figure legends are provided on a separate page.

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.

IRB Review and Informed Consent / Human subject protection

(see also above, under Subjects and Methods).All human research studies submitted to and published by CPDD must be compliant with the principles expressed in the Declaration of Helsinki.

The authors must state in the Methods section, ideally under the sub-heading Study Design, that the locally appointed ethics committee/institutional review board (IRB) has approved the research protocol, and that written informed consent was obtained from all subjects (or their guardian/s) prior to initiation of the study. The specific study site(s) and applicable IRB(s) should be explicitly named. For studies with multiple sites, such as population pharmacokinetic studies, the Editor may at his discretion append the specific sites in a supplementary online file due to space considerations. In those cases, a notation to that effect will be included in the “Methods” section of the paper.

Patients have a right to privacy that should not be infringed without informed consent. Identifying information should not be published in articles unless it is essential for scientific purposes and the patient (or their guardian/s) has given written informed consent for publication, which requires that the patient be shown the manuscript to be published. Identifying details should be omitted if they are not essential but patient data should not be modified in an attempt to attain anonymity.

If reporting animal experimentation, authors should indicate which institutional/national guidelines or law on the care and use of laboratory animals was followed. Authors should consider relevant published ethical standards such as "Guidelines for the welfare and use of animals in cancer research";

(Workman, Aboagye, Balkwill et al. Br J Cancer 2010; 102: 1555-1577) and reporting standards such as the ARRIVE Guidelines (http://www.nc3rs.org.uk/arrive-guidelines).

References

Notation within the text should be in sequential numeric superscript. References should appear at the end of the manuscript, cited in numerical sequence corresponding to their appearance in the text. The citation format of the American Medical Association Manual of Style (10th edition) should be used. Reference citations should contain all authors of the original report, unless there are more than 6 authors, in which case the first 3 authors should be listed, followed by “et al.”

Requirements for “Brief Reports”

As above, but fewer than 3,000 words of text, and a limit of 2 (total) figures and/or tables.

Letters to the Editor

Letters may address articles previously published in CPDD or issues felt to be of importance to CPDD readers. Authors are urged to keep letters to fewer than 500 words, although longer letters may be considered at the discretion of the Editor. Letters must be submitted through ScholarOne Manuscripts; authors must complete a copyright transfer and financial disclosure agreement, as described above.

For questions regarding Clinical Pharmacology in Drug Development or its editorial procedures, contact the editorial office: DJ.Greenblatt@Tufts.edu

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