Pharmaceutical Regulatory Affairs: Open Access provides the rapid Bi-annually publication of articles in all areas related to Regulatory Guidelines, Regulatory compliance, Medical devices regulations, Regulatory Affairs, Pharmaceutics, Pharmaceutical formulation, Biopharmaceutics, Drug development, Intellectual property rights, Drug discovery, Pharmaceutical care, Drug Delivery System, Pharmaceutical Sciences, Pharmaceutical Marketing, Clinical Trials, Pharmacovigilance.
Submit manuscript at www.scholarscentral.org/submissions/pharmaceutical-regulatory-affairs-open-access.html or send as an e-mail attachment to the Editorial Office at [email protected]
Policy Regarding the NIH Mandate
Pharmaceutical Regulatory Affairs: Open Access will support authors by posting the published version of articles by NIH grant-holders and European or UK-based biomedical or life sciences grant holders to PubMed Central immediately after publication.
Article Processing Charges (APC):
Pharmaceutical Regulatory Affairs: Open Access provides free access to all the published materials to its users/readers. However, the publisher does not get any institutional or organizational support to meet its publication and archiving expenses. Hence, the publisher relies exclusively on article processing charges of the authors furnished below.
The basic article processing fee or manuscript handling cost is as per the price mentioned above on the other hand it may vary based on the extensive editing, colored effects, complex equations, extra elongation of no. of pages of the article, etc.
Average Article prorcessing time (APT) is 55 days
Author Withdrawal Policy
From time to time, an author may wish to withdraw a manuscript after submitting it.
Changing ones mind is an authors prerogative. And an author is free to withdraw an article at no charge as long as it is withdrawn within 5 days of its initial submission.
Pharmaceutical Regulatory Affairs: Open Access is a scholarly research journals and it considers various types of articles for publication such as:
Research Article: A research article is a primary source. It reports the original study performed by the authors. A Results and Discussion section describes the outcomes of the data analysis. Charts and graphs illustrating the results are typically included followed by conclusion and References. The word limit for a research article should be 1500-6000. Each article should possess a section “Conflict of Interest”.
Review Articles: A review article is an article that summarizes the current state of understanding on a topic. A review article surveys and summarizes previously published studies, rather than reporting new facts or analysis. The preferable word count for review article should be 2500-9500. Review articles must explain:
Case Reports: Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness and adverse events. They can be shared for medical, scientific, or educational purposes. It is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. The word count for the case report will be 1000-2000. Case studies without proper discussion are not accepted for publication.
Commentaries/Perspectives: Perspective, opinion, and commentary articles are scholarly articles which express a personal opinion or a new perspective about existing research on a particular topic. The word limit for the Commentaries/perspectives should not be more then 1000-1800.
Editorials: Editorials are expert opinions on a specific field where the specialist is able to predict and analyze the future trends based on the current developments. Editorials are generally written by senior scientists, distinguished academicians and noble laureates that have extensive command over the field. The word limit for the editorials should not be more than 900-1200. Short Communication Short Communication is a description, viewpoints, and observations of the author referring facts, findings from other studies and writes a critical and brief analysis that would not exceed 500-1000 words.
Letters to the Editors: Letters to the Editors are reader’s views, opinions, comments, suggestions on various articles published in the journal. Often ‘Letters to the Editor’ elaborate, question, analyze and add value to the study. Letters to the Editors should not exceed 500-1000 words.
Disputes: All the disputes related to copyright violation and scientific misconduct will be thoroughly examined and if proved guilty, the Editor in Chief can reject or blacklist the author/ writings.
Pharmaceutical Regulatory Affairs: Open Access follows a prescribed set of article types with a specific format for manuscript. Type the entire manuscript, including figure legends, tables, and references, in font 12, in Times New Roman, double-spaced using Microsoft Word. Leave 1-inch margins on all sides. Manuscripts should be written succinctly and should cite select references that are directly relevant. For guidance on length of each article, see section on article types below.
Covering Letter is declaration of the corresponding author stating that the manuscript is original in all aspects and it is not published or under consideration for publication with any other publisher. The declaration must also include a statement that the study did not violate any national or international laws on human, animal and environmental rights. All the other authors that have contributed for the study are bound to obey the declaration signed by the corresponding author.
The title page must display the complete title of the study reflecting its overall objective followed by the complete list of all authors’ with their full names, affiliations; an abbreviated title for the running head (not to exceed 50 characters, including spaces); name and address of corresponding author, contact telephone, fax number, and e-mail address. Where necessary, identify each author’s affiliation by superscript numbers matched to the appropriate institution. The subsequent pages furnish and unfold the study. The manuscript must be clearly demarcated with the sub-headings, stated in Arabic numbers. Each and every page of the manuscript must be thoroughly numbered on top right corner of the page.
Abstract and Keywords
The manuscript must begin with an abstract of not more than 500 words that captures the entire summary of the study, including its scope, methodology, findings, conclusion and limitations. At least five important terminologies reflecting the theme of the manuscript must be placed as keywords at the end of the abstract.
All the manuscripts must start with an introduction to begin with, which sets the tone and the foundation for the study. Introduction provides basic information of the study by referring similar such studies elsewhere. Introduction briefly discusses various key aspects of the study, raising valid and important questions, which may be answered subsequently as the study progresses.
Methods and Materials
Methods and materials section discusses the research methods deployed to conduct the study, including the sample size and technique. It also discusses the tools used for the data collection, and interpretation.
The author draws various conclusions by analyzing the information extracted by analyzing the data elicited from the study. These are findings that the author/s would get at the end, may or may not coincide with the hypothesis set by the author/s at the beginning of the study.
Discussion and Analysis
The collected information is analyzed statistically by applying various relevant formulas that are universally acceptable and the data is analyzed to produce observations and statements that are backed by valid evidences. This part of the manuscript generally represents tables, graphs, diagrams, charts that reinforce the values and information discussed in the manuscript as text.
Tables, Figures, Graphs and Diagrams
All the tables, graphs, diagrams and images provided in the text must have captions and legends, indicating their appropriate location in the manuscript. All the tables must be presented in the numerical order in Excel format, charts and diagrams must be presented in excel/word format and the images, diagrams and pictures must be presented in jpeg format.
Conclusions are generally drawn from the findings that are summarized tat the end to draw valid findings of the study.
Limitations & Recommendations for Future Studies
Authors must define and state the limitations if any within the scope of the study and must clearly state it to avoid confusions. Authors must also suggest recommendations for future studies on this area.
This is an important part of the manuscript where author/s cites the source of the information referred in the manuscript to avoid copyright violation. The Advanced Practices in Nursing follows Chicago style of referencing. Author/s must carefully arrange the references as stated below.
Article with single author: Last Name, First Name. “Article Title.” Journal Short Name in italics Volume Number (Year Published): Page Numbers.
E.g. Smith, John. “Studies in Pop Rocks and Coke.” Weird Science 12 (2009): 78-93.
For an article written by two or more authors: List them in order as they appear in the journal. Only the first author’s name should be reversed, while the others are written in normal order. Separate author names with a comma and place ‘and’ between last two authors.
E.g. Smith, John, and Jane Doe. “Studies in Pop Rocks and Coke.” Weird Science 12 (2009): 78-93.
E.g. Smith, John, Austin Kaufmann, and Jane Doe. “Studies in Pop Rocks and Coke.” Weird Science 12 (2009): 78-93.
For more than 4 authors: E.g. Smith, John, Austin Kaufmann, Jennifer Monroe, and Jane Doe, et al. “Studies in Pop Rocks and Coke.” Weird Science 12 (2009): 78-93.
Citation of book: Grazer, Brian, and Charles Fishman. A Curious Mind: The Secret to a Bigger Life. New York: Simon & Schuster, USA, 2015.
Citing News or magazine article: Farhad, Manjoo. “Snap Makes a Bet on the Cultural Supremacy of the Camera.” New York Times, March 8, 2017.
Book review: Michiko, Kakutani. “Friendship Takes a Path that Diverges.” Review of Swing Time, by Zadie Smith, New York Times, November 7, 2016.
Thesis or Dissertation: Cynthia, Lillian Rutz. “King Lear and its Folktale Analogues.” PhD Diss., University of Chicago, (2013): 99–100.
For more details on Chicago reference style please refer to https://libguides.murdoch.edu.au/Chicago
Author/s must acknowledge all the persons, institutions, organizations and the funding agencies that are resourceful in conducting the study.
Conflict of Interest
Authors must clearly disclose commercial associations that might create a conflict of interest in connection with submitted manuscripts and must give credit to any ghostwriters involved in the writing of the manuscript. This statement should include appropriate information for EACH author, thereby representing that competing financial interests of all authors have been appropriately disclosed.
Authors can share all the supplementary information that they could not share in the manuscript as appendix. Appendix also carries questionnaires, guidelines, and the universal standards followed in conducting studies involving animals.
A bridged technical terms and jargons used in the study are expanded and must be placed at the end of the study for clear understanding of the readers.
License and Copyright
The type of use is dependent on user license. The author retains the copyright and grants publishing rights to the publisher. Creative Commons License CC BY-NC-ND 4.0 allows articles to be read and shared online with certain conditions such as the original source must be cited and the research work may not be used for commercial purposes. Derivatives such as article translations and adaptations should not be distributed. Certain requirements by the funder are conformed by applying the Creative Commons Attribution 4.0 International License (CC BY 4.0) as per the requirement.