Journal of Bioanalysis & Biomedicine

Naji M. Najib

Publications

• Research Article
  Effect of Replicate Design on Drug Variability and Bioequivalence in Humans
  Author(s): Naji M. Najib, Isam Salem and Nasir M. IdkaidekNaji M. Najib, Isam Salem and Nasir M. Idkaidek
  
  The purpose of this study is to investigate the effect of using replicate design on the intra/inter subject variability and bioequivalence of drugs in healthy volunteers. Model drugs used for analysis were amoxicillin/clavulanic acid combination. 24 healthy subjects participated in this study using 4-phase replicate cross over design. Individual disposition kinetic parameters of areas under plasma concentrations (AUC0-t) and maximum concentration (Cmax) were calculated by non-compartmental analysis using Kinetic program V 4.2 using all phases. The 90 % confidence intervals for log-transformed AUC0-t and Cmax were calculated for phases I & II; then for phases I, II and III; and for phases I, II, III and IV respectively. The intra and inter-subject variability values did not show a trend to decrease by the increase in phases included in analysis in both drugs and for both parameters.. Read More»
  DOI: 10.4172/1948-593X.1000003

  Abstract PDF