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 AUGUST ISSUE PUBLISHED
  • AUGUST 2020 Issue has been successfully launched on 1 August 2020.

Abstract

IMPLEMENTATION OF BIOEQUIVALENCE STUDIES FOR APPROVAL OF GENERIC DRUG PRODUCTS IN SUDAN: CURRENT STATUS

Abubakr O. Nur*, Abdelhalim B. Mahmoud, Zuheir A. Osman, Mohammed E. Abdelmageed

ABSTRACT

Number of registered medicines in Sudan approaches 5000, of which 84% were account as generic products that imported to constitute 70% of the total Sudanese drug market. National Medicines and Poison Board, as a national drug regulatory authority, has adopted bioequivalence study as one among other requirements for approval or re-approval of these generics. This study aims to highlight the current situation and the associated problems with regard to implementation of BE studies as a regulatory tool for drugs market authorization in Sudan through retrospective reviewing of relevant documents bearing in mind the applicability of biowaiver concept. Results has indicated that study cost, approval delay, limitation of available or approved bioequivalence centers and wavering in bioequivalence studies recommendations between World Health Organization and Harmonized Arab Guidelines on bioequivalence studies were the main problems associated with the bioequivalence implementation. Moreover, the study revealed a discrepancy in the consideration of BCS based biowaiver concept by the National Medicines and Poison Board for the approval of biowaiver eligible drug products, as compared to relevant guidelines of World Health Organization and the Harmonized Arab Guidelines. The study concluded that revision of NMPB documents related to implementation of bioequivalence studies so as to remove the existing discrepancies, consideration of BCS based biowaiver concept in the approval of drug generic products, establishment or nomination of more national bioequivalence centers and conduction of effective post marketing surveillance would improve the legislation and regulation of both biowaived and non-biowaived generic drug products

Keywords: Bioequivalence Studies, National Medicines and Poison Board, BCS Biowaiver, Harmonized Arab Guidelines.


[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