Photo Gallery

Login

Search

News & Updation

  • Updated Version
  • WJPPS introducing updated version of OSTS (online submission and tracking system), which have dedicated control panel for both author and reviewer. Using this control panel author can submit manuscript
  • Call for Paper
    • WJPPS  Invited to submit your valuable manuscripts for Coming Issue.
  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.
  •  
  • WJPPS Impact Factor
  • Its our Pleasure to Inform you that WJPPS Impact Factor has been increased from  7.454 to 7.632  due to high quality Publication at International Level

  • ICV
  • WJPPS Rank with Index Copernicus Value 84.65 due to high reputation at International Level

  • WJPPS OCTOBER ISSUE PUBLISHED
  • OCTOBER 2020 Issue has been successfully launched on 1 October 2020.

Abstract

CTD – A CRITICAL DOCUMENT FOR DOSSIER SUBMISSIONS: AN OVERVIEW

K. P. R. Chowdary*, K. Ravi Shankar and G. Saranya

ABSTRACT

New drug development process is highly regulated. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its safety, efficacy and quality. A dossier containing detailed information about the drug and results of the studies carried out in its development process has to be submitted to the regulating bodies for getting marketing authorization. CTD (Common Technical Document) is critical for dossier submissions. Literature on CTD, its structure and modules and details of information to be included in CTD and eCTD submissions are reviewed in this article.

Keywords: New Drug Approval Process, Dossier, CTD, eCTD.


[Full Text Article]

Call for Paper

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Online Submission

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More

Email & SMS Alert

World Journal of Pharmacy and Pharmaceutical Sciences (WJPPS)
Read More