Journal of Bioanalysis & Biomedicine

Laura Zufía

Publications

• Research Article
  Validation of an LC Method for Therapeutic Drug Monitoring of Voriconazole in Patients
  Author(s): Laura Zufía, Azucena Aldaz, Nerea Ibáñez and Joaquín GiráldezLaura Zufía, Azucena Aldaz, Nerea Ibáñez and Joaquín Giráldez
  
  An accurate and precise LC method using diode array detection for the determination of voriconazole in human serum/plasma samples has been developed and validated for use in pharmacokinetic studies. A harmonized validation strategy based on the accuracy profiles was used as a suitable tool to guaranty the quality of the results obtained by the use of the analytical validated methodology in a routine setting and to ensure the risk of obtaining the future measurements outside the previously fixed acceptance limits. As pointed recently the FDA, a weighted 1/x2 linear regression model ranging from 0.25 to 10.35 mg/L was selected as the simplest calibration model that maximized the accuracy all over the range. Relative bias was < 7%, assay imprecision was always < 4% and mean extraction recovery from plasma was > 90%. So, accuracy did not excee.. Read More»
  DOI: 10.4172/1948-593X.1000019

  Abstract PDF