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

Gurer, Cagri; ÇAKMAK PEHLİVANLI, AYÇA; Demircigil, GONCA

doi:10.1186/s40064-016-2527-4

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

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

SPRINGERPLUS, cilt.5, 2016 (SCI-Expanded)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 5
Basım Tarihi: 2016
Doi Numarası: 10.1186/s40064-016-2527-4
Dergi Adı: SPRINGERPLUS
Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Açık Arşiv Koleksiyonu: AVESİS Açık Erişim Koleksiyonu
Gazi Üniversitesi Adresli: Evet

Özet

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.