The Japanese Journal of Clinical Pharmacology and Therapeutics（the Journal）is a journal published by the Japanese Society of Clinical Pharmacology and Therapeutics（the Society). The Journal publishes papers on all aspects of interdisciplinary research concerning human pharmacological treatment, with the goal of contributing to the advancement of the fields of clinical pharmacology and therapeutics not only within Japan but globally. The areas of study from which the Journal awaits submission of original papers are as follows：clinical studies concerning the development of new medicines or treatments intended for human use and the ethics thereof；translational research；research on individualized pharmacological treatment including pharmacogenomics；research on interactions with medicine, environmental factors, and nutrition relating to variability in drug responses；pharmacokinetics and pharmacodynamics research；pharmacometrics research；pharmacoepidemiology research；research on medical economics relating to pharmacological treatment；regulatory science research；topics of the education of clinical pharmacology and therapeutics；and any other related topic that authors consider to be within the purpose and goal of the Journal. The target audience for the Journal comprises medical doctors, pharmacists, nurses, clinical research coordinators（CRCs), and others involved in pharmacological therapy, who are members of the Society. Moreover, the Journal offers a platform for vigorous discussion of political issues of medicines and review articles related to the above fields.

1.Types of Articles Eligible for Submission

The Journal accepts Original Articles, Short Communications, Case Reports, Review Articles, Forums, Letter to the Editor, and Reports. Submitted articles must be previously unpublished in other journals nor currently under review by other journals.

• Original Article：

  Japanese Journal of Clinical Pharmacology and Therapeutics（JJCPT）will accept submissions of articles which aim to answer previously unknown or unsolved issues in the discipline of clinical pharmacology and therapeutics. They may be experimental, observational, and randomized clinical trials with intervention in design. Submissions of pharmacoepidemiologic studies including meta-analyses of randomized trials, cost-effectiveness analyses on health care databases, and analyses of adverse drug reaction databases are also welcome.

  Short Communication：

  An interim report that justifies urgent publication, and one that would ultimately be published in final form as part of an Original Article.

  Case Report：

  A clinical case report that raises important aspects to be discussed in the light of pharmacological therapy, such as adverse reactions or interactions, using information from a single patient or a few patients.

  Review Article：

  An article that expresses the author's views on the results of a highly relevant Original Article within the Journal's fields.

  Forum：

  Accounts, recommendations, or proposals to research ethics, regulations of academic or clinical experiments, and other areas of clinical pharmacology and therapeutics which may not be considered for publication in original articles may be accepted in this category.

  Letter to the Editor：

  Expresses a reader's inquiries or opinions about a paper or article published in the Journal.

  Report：

  An article about the activities of the Society designed to communicate relevant information via the Journal（for example, reports by the awardees of the Foreign Clinical Pharmacology Training Program after the completion of the program).

2.Submission Requirements

Members and nonmembers of the Society may submit articles. However, if the first author is not a member of the Society, a submission fee must be paid（see 12.1).

3.Author Requirements

To be published as an author, the following three requirements must be satisfied：He/she 1）has made a suitable contribution to the paper's conception and design, acquisition of data, analysis, and discussion, 2）participated in drafting the paper or in critical proofreading concerning its essential intellectual content, and 3）was responsible for final confirmation of the submitted manuscript.

4.Editorial Review

A manuscript will be accepted or rejected for publication upon review by a number of specialists. If it is accepted, revisions to the manuscript may be requested. Articles are generally published in order of submission, but due to circumstances of judging or editing, the order may be changed. Furthermore, for clinical studies with human subjects, statements of compliance with the Declaration of Helsinki, documentations of the approval by the ethics committees of relevant medical institutions, and documentations of the acquisition of written informed consent from participants of the study must be clearly written in the manuscript.
Furthermore, if a clinical study submitted to the Journal is prospective and confirmatory in design, authors are required to register the study with a registry that meets the standards of the International Committee of Medical Journal Editors（ICMJE), such as the jRCT, UMIN Clinical Trials Registry.

5.Submitting a Manuscript

• 5.1 Submit the manuscript at the designated URL（http ://mc.manuscriptcentral.com/jscpt). This URL is available on the Society's website（the Journal page), and an online submission manual（in Japanese）is also available there. Please follow all the instructions within the submission system regarding file formats.
    If none of the authors of the manuscript is familiar with Japanese, please email the set of required documents（a cover letter, manuscript including figures and tables, COI forms）to the secretary of the Society（submission-jscpt@dream.jp).
• 5.2 During submission, the corresponding author must create an individual password, and he or she thereafter assumes personal responsibility for it.（The Society office does not manage user passwords.）
• 5.3 Within the electronic submission system, in the process of submitting the article, the first author will be asked to confirm whether he or she is a member of the Society, to declare that there is no duplicate submission, to agree with copyright transfer of the article to the Society in case of publication, and so on. The answers to these questions are recorded in the submission system and take the place of a written oath. The corresponding author who handles the electronic submission will be asked, as part of the process, questions regarding Conflict of Interest（COI）；however, besides this, the corresponding author must also attach the designated COI form available at the Society's web site for all coauthors. Review of the attachment article will be begun only after confirmation from the Society that the document declaring all authors' COI has been submitted（see section 9, Disclosure of Conflicts of Interest).

6.Length of Articles

• 6.1 Standard lengths for manuscripts submitted in either Japanese or English are as follows：8 Journal pages（with a limit of 6 figures/tables/photos）for Original Articles, Forums, and Review Articles and Reports；4 Journal pages（with a limit of 2 figures/tables/photos）for Short Communications, Case Reports；and 2 Journal pages for Letter to the Editor.
• 6.2 English manuscripts should be double-spaced（A4 page-size, 25 lines). When published, 9,000 words translate roughly to 1 Journal page.
• 6.3 Upon the request from authors, the editor in chief（EIC）may allowed them to present additional data that are not contained in the printed form of articles in JJCPT as supplemental data（e.g., tables, figures）in their electric versions of articles and/or in offprint form of the articles. EIC will make the final decision by taking other editors opinions into account. Authors are requested to express their intention for presenting a part of the data as supplemental data separately when they make the first submission. Supplemental data should be clearly indicated in the original manuscript. Authors will be charged an additional costs of supplemental data in the offprint and the electronic form of the article in addition of the regular form of the printed article of JJCPT.
• 6.4 For manuscripts that fall outside the above guidelines, the editorial board will decide at its discretion.

7.Format of Manuscripts

• 7.1 The first page of a manuscript should include the article's title, authors' names, affiliated institutions and their addresses（only the correspondent author's location is necessary), and the authors' contact information, phone numbers, fax numbers, email addresses, and the destination for the proofread document. For articles seeking fast-track publication（see 12.3), please write so in red on the first page. Manuscript pages must be numbered.
• 7.2 If the author is publishing data which he or she obtained while working as a business-affiliated researcher dispatched from his or her company or studying as an adult graduate school student in a research institution, he or she must give not only the name of the institution where the research was conducted and the name of company he or she is employed.
• 7.3 All articles that are intended to publish in Japanese either as a regular article or as a forum category should include an abstract in English of about 250 words and 5 or fewer keywords on the second page. The Japanese translation of the abstract should be included. The corresponding authors should be indicated with their affiliation and its mailing address. Authors are requested for asking proofreading of their original manuscript written in English by a native English speaker prior to submission. They should send the documentary evidence of proofreading with the submitted article.
• 7.4 For articles that are intended to publish in English either as a regular article or as a forum category should include an abstract of about 250 words and 5 or fewer keywords on the second page. No Japanese translation of the abstract is required. Authors are requested for asking proofreading of their original manuscript by a native English speaker prior to submission. They should send the documentary evidence of proofreading with the submitted article.
• 7.5 In principle, Original Articles and Short Communications should include an Introduction, Methods, Results, Discussion, Conclusion, Disclosure of Funding Sources, COI, Acknowledgements, and References. A Forum need not follow the purpose, methods, results, and discussion scientific paper format. There is no particular format for Review Articles, Case Reports, Correspondences, or Reports.
• 7.6 Generic names（JAN or INN）should be used for medicines It is not necessary to label salts. If you need to write the trade name of a drug, please write the generic name；then include the registered trade name within parentheses and indicate it with an R or ® . Example："We used pravastatin（Mevalotin Tablets^®)."
• 7.7 When annotating pharmacokinetic parameters, please conform to the notation format recorded in Eur J Clin Pharmacol. 1988；35：1-7.
• 7.8 For units of measurement, routes of administration, and so on, please use the standard English abbreviations（e.g., mm，cm, mL, dL, L, g, kg, sec, min, hr, wk, yr, LD₅₀, N/10, po, iv, sc, im, ip, t_1/2, Vd).
• 7.9 Authors may be allowed to use abbreviations in text, but they should give their full-spellings when they appear for the first time in text.
• 7.10 Please use the labels"Figure","Table"and"Photo."as appropriate, and use Arabic numerals to indicate the order of appearance within the text, if there is more than one figure/table/photo. Along with these, a caption should be included and, if necessary, explanations.

8.References and Citations

• 8.1 Please indicate citations with a number in an open parenthesis to the upper right of the appropriate section of the text, then list citations individually in the References section at the end of the text.
• 8.2 If there are six or fewer authors, please list all their names. If there are seven or more authors, please exclude the seventh and subsequent authors and write"the 6^th author's name, et al."Please separate authors' names with a comma. Please do not insert a comma between authors' family and given names, and do not insert a period after initials.
• 8.3 Authors should underline journal names in the submitted manuscript. Use standard abbreviation for journal names, but do not put periods. For the volume number, please use Bold typeface. When citing literature written in Japanese, please add"（in Japanese）"at the end. Please attach Digital Object Identifier（DOI）of each article whenever available at the end of the respective bibliographic information.
• 8.4 Page numbers of references must indicate its beginning and ending pages, unless the reference consists of only one page.
• 8.5 Authors should underline book titles in the submitted manuscript.
• 8.6 When citing websites, insert the URL and the date accessed.
• 8.7 Please follow the formatting guidelines below for your citations.

  Journals :
  Journals：Author. Title. Journal name（underline). Year of publication；Volume（Issue）：Pages（beginning-ending).

  Citation of English Literature :

  • Example 1) Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, et al. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012；367（25)：2407-18. doi：10.1056/NEJMoa1205511.

  Citation of Japanese Literature :

  • Example 2) Kumagai Y. Placebo-controlled, double-blind study to evaluate the safety, tolerability and pharmacokinetics of intravenous acetaminophen formulation（TRM-1106）in Japanese healthy subjects. J Clin Ther Med. 2013；29（10)：875-87.（in Japanese)

  Books :
  Author. Title.（Editor). Book title（underline). Place of publication：Publisher, Year of publication：Pages（beginning-ending).

  • Example 3) Giacomini KM, Sugiyama Y. Membrane transporters and drug response. Brunton LL, Lazo JS, Parker KL（Eds). The Pharmacological Basis of Therapeutics, 11th ed. NY : McGraw-hill, 2006 : 41-70.

  Websites :

  • Example 4) National Institutes of Health. Institutional clinical and translational science award（RFA-RM-06-002). October 12, 2005.［http ://grants.nih.gov/grants/guide/rfa-files/RFA-RM-06-002.html（accessed 2014-10-1）］

9.Disclosure of Conflict of Interest（COI)

• 9.1 In accordance with the Regulations for the Management of Conflict of Interest（COI）issued by the Society's COI Committee, all authors of submitted articles must report to the Society any and all COI information with business enterprises in relation to the submitted articles about themselves, their spouses, first-degree family, and those who share property and assets using the designated form（JSCPT Form 2, available on the homepage of the Society's website). Relevant COI information should include that emerged within one year from
  the data of article submission.
• 9.2 If the review process of an article is prolonged longer than one year, all authors of the article must update any and all COI information that emerged within one year from the date of accept for publication about themselves, their spouses, first-degree family, and those who share property and assets using the JSCPT Form 2.
• 9.3 The COI information will not be open to reviewers of submitted articles.
• 9.4 In the case of a study conducted at the request of a business enterprise, all interests relating to the clinical research and to the corporation must be disclosed（including disclosure of funding).
• 9.5 All authors must describe the COI information and the sources of funding between the end of articles and Acknowledgements or Reference. If no relevant COI information exists, authors must describe so（e.g., “There is no conflict of interest to be disclosed” or “No potential conflicts of interest were disclosed“).

10.Duplicate Submission

In the event of identification of duplicate submission, the Editor-in-Chief will reject publication even if the paper had already been accepted and he or she may disclose the event concerned in the Journal.

11.Copyright

Copyrights for all items published in the Journal belong to the Society.

12.Submission and Publication Fees

• 12.1 If the first author is a member of the Society, submission fee is free of charge, but if he or she is not a member, a submission fee of ￥10,000（equivalent to the annual membership fee）per article must be paid.
• 12.2 The publication fee is ￥5,000 per page, up to 8 pages for Original Articles, Forums, and Review Articles, and Reports；up to 4 pages for Short Communications, Case Reports. For any pages in excess of these limits will cost ￥10,000 per page. Fees for figures, tables, photos, and color photos are added at actual cost.
• 12.3 After the completion of the review, those who want their paper to be published more promptly than in order of submission（fast track publication）will have to pay double the total normal publication fee.

13.Offprint Runs

• 13.1 All offprint runs incur a printing fee, and they may be requested at the time of the author's proof in units of 50 copies.
• 13.2 In cases where the submission was requested by the editorial board, the corresponding author will be gifted 10 to 30 copies free of charge.

14.Other

• 14.1 All Original Articles will be submitted for consideration for the Scientific Paper Award from the Japan Research Foundation for Clinical Pharmacology.
• 14.2 Accepted articles will be archived as e-journals in the J-STAGE.

Enacted January, 2016
Revised March, 2017
Revised January, 2018
Revised April, 2020