Journal of Bioequivalence & Bioavailability

Rana Hasan

Publications

• Research Article
  Effect of Truncated AUC Method on Drug Bioequivalence in Humans
  Author(s): Naji M. Najib, Isam Salem, Rana Hasan and Nasir M. IdkaidekNaji M. Najib, Isam Salem, Rana Hasan and Nasir M. Idkaidek
  
  The purpose of this study is to investigate the eff ect of using truncated area under the curve AUC) method on the bioequivalence of different drugs in healthy volunt eers. Model drugs used clopidogrel, glimepiride, losartan , carvedilol, carbamazepine, diazepam, donepezil, tra madol and repaglinide. 24 – 38 healthy subjects participa ted in each study using cross over design. Individual disp osition kinetic parameters of areas under plasma concentrat ions (AUC 0-t , AUC 00 ), maximum concentration (C max ) and time to reach maximum concentration (T max ) were calculated by non-compartmental analysis using Kinetica progra m V 4.2 using all data points. In addition, truncated A UC was calculated up to median T max of reference product. No di- rect correlation was shown between study results du e to AUC truncation. The 90 % confidence intervals for l og- transformed AUC 0-t , AUC .. View More»
  DOI: 10.4172/jbb.1000017

  Abstract PDF