期刊名称：THERAPEUTIC INNOVATION & REGULATORY SCIENCE
 期刊简介(About the journal)
投稿须知(Instructions to Authors)
编辑部信息(Editorial Board)
About the journal
Therapeutic Innovation & Regulatory Science (TIRS) is the official journal of DIA, publishing bi-monthly. TIRS publishes peer-reviewed original articles and commentaries across all phases of medical product discovery, development, regulation, and use. At a time of rapid change in medical science innovation, TIRS encourages international, cross-disciplinary, translational contributions that will help inform and drive innovation and regulatory science.
Topics in the journal include:
quality manufacturing
drug shortages
targeted/personalized drug discovery/development/clinical use
design of clinical trials (all phases including biostatistics)
combination products and companion diagnostics
biomarkers
safety
special populations
collaboration among patient/advocacy groups, academia, industry, and the regulatory community
international collaboration
policy and bioethics
novel tools for scientific/clinical communication
sustainability of innovation/financial models for product development/pricing
Instructions to Authors
Manuscripts for Therapeutic Innovation & Regulatory Science are to be submitted online at http://mc.manuscriptcentral.com/tirs; authors will be required to set up an account in the SAGE Track system powered by ScholarOne. Authors will be guided stepwise through the creation and uploading of all manuscript files. All correspondence, including notification of the Editor's decision and requests for revision, will take place via email. Upon acceptance, authors will be asked to complete a Journal Contributor's Publishing Agreement. An email will be sent to the corresponding author confirming acceptance of the manuscript together with a link to the online agreement. Average time from submission to first decision: 27 days.
Please read and follow the instructions to authors outlined below (PDF version) (Submission Template and Checklist). Failure to follow these instructions may delay manuscript processing. Please contact the Editorial Office with any questions:
Judy Connors, Publications Manager
Managing Editor, DIA
800 Enterprise Road, Suite 200
Horsham, PA 19044 USA
215-293-5860
Email: Judy.Connors@diahome.org
Jenny Kimbel, Senior Editorial Assistant, DIA
Managing Editor, DIA
800 Enterprise Road, Suite 200
Horsham, PA 19044 USA
215-442-6164
Email: Jenny.Kimbel@diahome.org
1. Editorial Policy
Prior publication. Manuscripts are accepted for consideration with the understanding that they have not been published elsewhere and are not concurrently under review elsewhere. Papers that have been presented at scientific meetings are accepted for consideration.
Ethics, privacy guidelines. When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised, or current local regulatory requirements, whichever affords more protection. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the study. When reporting experiments on animals, authors should be asked to indicate whether the institutional and national guide for the care and use of laboratory animals was followed.
Patients have a right to privacy that should not be infringed without informed consent. Identifying information, including patients' names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent/guardian) gives written informed consent for publication. Informed consent for this purpose requires that a patient who is identifiable be shown the manuscript to be published. Authors should identify individuals who provide writing assistance and disclose the funding source for this assistance.
Identifying details should be omitted if they are not essential. Complete anonymity is difficult to achieve, however, and informed consent should be obtained if there is any doubt. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic pedigrees, authors should provide assurance that alterations do not distort scientific meaning, and editors should so note. When informed consent has been obtained it should be indicated in the published article.
2. Manuscript Preparation
Style. Manuscripts, including references, are to be prepared according to the AMA Manual of Style, 10th ed. (AMA).
Abbreviations and units of measurement. Terms appearing frequently may be abbreviated, but they should be spelled out at first citation, with the abbreviation following in parentheses. Units of measurement should be in accord with the Systéme International (SI). Acronyms and abbreviations should be spelled out in the article title.
Drug and dosage selection. The authors are expected to make every effort to ensure the accuracy of the information in an article, particularly with regard to drug selection and dose. However, appropriate information sources should be consulted, especially for new or unfamiliar drugs or procedures. It is the responsibility of every practitioner to evaluate the appropriateness of a particular opinion in the context of actual clinical situations and with due consideration to new developments.
Permissions. If a figure or table has been previously published, a credit line should be included, and authors must obtain a letter of permission from the publisher. A copy of each permission letter must be submitted with the manuscript.
Financial support & conflict of interest. All papers must indicate the affiliation of each author and include a statement for each author whether they have any financial arrangement or connection with the sponsor of the study or the organization that provided support for the work. Any conflict of interest and funding information should appear on the title page of the submitted manuscript. In addition, authors of accepted papers will be required to fill out a conflict of interest form. Statements of funding sources and conflicts of interest will be published in the article.
Editor's Note: These instructions for manuscript preparation assume that certain resources are available to the author. Although compliance with these instructions will increase the probability of publication in the Journal, authors should not be discouraged from submitting manuscripts that do not completely comply with these instructions. If an author feels his/her manuscript is worthy of publication in the Journal, he/she should do as much as possible to comply, then submit it to the Editor. If the Editor and Editorial Board agree on its desirability for publication, the Editorial Office will assist in satisfying the Publisher's manuscript preparation requirements.
3. Manuscript Format and Organization
Acceptable file types. Manuscript files should be submitted in Microsoft Word format. Pages should be 8.5 x 11” with 1-inch margins on all sides; double-space the text using 12-point font throughout. Page numbers should appear on each page. Submissions should be written in clear, understandable, grammatically correct American English. Select the following link for English language editing services.
Article Submissions
Length. In most cases, submissions of regular manuscripts should not exceed 5000 words, including tables, figures, and references. However, in certain cases (eg, comprehensive review papers), a higher limit may be appropriate. Authors are encouraged to contact the Editor via the editorial office if they feel that a higher limit would serve the best interests of readers.
Title page. Page 1 should include: a) the title of the article; b) the full name[s] of the author[s] with degree[s]; c) affiliations [eg, job title, department, institution, city, and state or country where the work was done], indicating which authors are associated with which affiliations; d) acknowledgment of grant support and of individuals who were of direct help in the preparation of the study; e) the name, date, and location of DIA Workshop at which paper was presented, if appropriate; f) the name and address, including email address, of the author to whom correspondence is to be sent.
Abstract/keywords. Page 2 should include the title of the article followed by a 1-paragraph abstract, which should be about 150 words. The abstract should summarize the main points of the article, the purpose of the study, basic procedures followed, main findings, and principal conclusions. Following the abstract, list 5-6 keywords for indexing.
Text. Papers should be organized as follows: Introduction, Materials and Methods (for experimental papers), Results, Discussion, and Conclusions. Other descriptive headings and subheadings may be used, if appropriate. The methods, apparatus (including manufacturer's name and location), and procedures should be identified in sufficient detail to allow other investigators to reproduce the results. References should be given for all discussions of previous studies and for all nonstandard methods used. Trade names may appear in parentheses and should be capitalized. Patients' identification, names, initials, or hospital numbers should not be used.
References. Type references double-spaced and number them consecutively in the order in which they are first mentioned in the text (not alphabetically), per AMA style. List up to 6 authors; for references with more than 6 authors list the first 3 followed by “et al.” Authors are responsible for the accuracy and completeness of the references.
Tables and figures. Number each table and figure consecutively as it should appear in the article; each table and figure must be cited within the article text. Add placement instructions on a separate line immediately after the paragraph in which the table/figure is mentioned (ie, “[insert Figure 1 about here]”). Place figure captions and tables at the end of the manuscript, after the references; do not embed tables or figures within the manuscript text. Submit figure images separately from the manuscript file. See below for further details. Note: There is a charge to print figures in color ($800 for the first page, $200 for each additional page). Color reproduction online is free of charge, and figures submitted in color will appear as submitted in the online issue.
Tables: Tables should be submitted in an editable format; Microsoft Word or Excel tables are preferred. Number each table in order as it should appear in text and include a brief title. Add footnotes if needed at the bottom of the table. All tables will be reformatted and typeset in the journal’s table style.
Figures and artwork: Submit images at or slightly larger than the final publication size (3.5-7 inches wide [9-18 cm]), with text sizes proportional to the image. Remove unneeded white space around images. Line-based artwork such as graphs and charts should be submitted in the format they were originally created (eg, Word, Excel, or PowerPoint file); for line art that is scanned, resolution should be 1000 dots per inch (dpi). Photos and halftone images should be submitted as TIFF, EPS, PSD, or JPEG files at minimum 300 dpi resolution.
Supplementary data. Supplementary online data offer the author additional possibilities to publish supporting material in the form of high-resolution images, background datasets, video/animation sequences, sound clips, etc. A URL for the supplementary material will be added to an article, and a link will be provided in the online version. Acceptable video file types are QuickTime (*.mov), MPEG Movie (*.mpeg), and Miscrosoft AVI Video (*.avi); acceptable audio files include Windows Media Player (*.wma) and MP3 (*.mp3).
Cite any supplementary material within the manuscript and submit the file separately. Provide a concise and descriptive caption for each file. Place an "S" before supplementary table and figure numbers (eg, Table S1).
Other Types of Submissions
Rapid Communications. The goal of this type of submission, which will be peer reviewed, is to facilitate the opportunity to publish empirical research findings in a rapid manner: both review of submissions and publication of accepted manuscripts will be expedited. Manuscripts should not exceed 1750 words. Additionally, 2-3 figures and/or tables and up to 5 references are permitted. Since articles appearing in this category will be peer-reviewed publications, they should be regarded as the single report of the original data presented: more detailed and lengthy versions will not be considered. However, this vehicle may be ideal in certain circumstances, such as concise reports of preliminary data from pilot studies, and reports of empirical data validating a new measurement methodology against the currently accepted gold standard.
Expert Commentaries. Expert commentaries will be written by acknowledged authorities in their fields (often by invitation, although all such experts are encouraged to submit manuscripts in this category, in which the Editor alone will determine suitability for publication). The goal of this category is to allow the author more freedom than is usually available to express personal insights, views on the likely development of his/her field of study, and perspectives that may influence this development to the benefit of patients.
Letters to the Editor. Letters may address articles published in the Journal or provide thoughts and insights on a specific topic not directly related to a specific Journal publication. In the first case, they should be no longer than 500 words (excluding name, affiliation, and references), and may have up to 5 references. The author(s) of the original article will be given the opportunity to reply to letters in a response of similar length. To keep discussion timely, letters should be received relatively soon after the publication of the original article. In the second case, letters should address a topic of timely interest and be no longer than 1000 words. As with all other submissions, publication decisions by the Editor are final.
4. Peer-Review and Production Process
Manuscripts are examined by the Editor and by 2 additional reviewers. We request that authors submit up to 3 suggested reviewers for their paper, to ensure that the manuscript is reviewed by someone with expertise in the subject matter and to expedite the process and facilitate timely review. All material accepted for publication is subject to copyediting. Authors will receive page proofs before publication, and should answer all queries and carefully check all editorial changes at this point. Authors are responsible for the scientific content and for all statements made in their work, including changes made by the copy editor and authorized by the corresponding author after review of page proofs. While every effort is made by the Publisher and Editorial Board to see that no inaccurate or misleading data, opinion, or statement appears in the Journal, they wish to make it clear that the data and opinions appearing in the articles and advertisements herein are solely the responsibility of the contributor or advertiser concerned. Accordingly, the Publisher, the Editorial Board, and Editor, and their respective employees, officers, and agents, accept no responsibility whatsoever for the consequences of any such inaccurate or misleading data, opinion, or statement. If a reviewer suspects that a submitted paper is a duplicate publication, fraudulent, plagiarized, or has other concerns about the integrity of the data or the paper, this will immediately be reported to the Editor. Decisions regarding publication will be made by the Editor, in consultation with the Managing Editor. All decisions by the Editor are final.
Editorial Board
Editor-in-Chief:
Associate Editors:
Associate Director, Editorial Services:
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