Pooled bioequivalence study database from Turkey: characterization of adverse events and determination of split points based on Gini Index as a promising method


Creative Commons License

Gurer C., ÇAKMAK PEHLİVANLI A., Demircigil G.

SPRINGERPLUS, vol.5, 2016 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 5
  • Publication Date: 2016
  • Doi Number: 10.1186/s40064-016-2527-4
  • Journal Name: SPRINGERPLUS
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Gazi University Affiliated: Yes

Abstract

Background: Manufacturing of and medication with generic drugs is increasing around the world. Bioequivalence (BE) studies are being performed routinely by Contract Research Organisations (CROs) in Turkey. However, an overall evaluation for the attended volunteers, examined Active Pharmaceutical Ingredients (APIs) and the observed adverse events have not been studied in the field.