Pharmaceutical Research

, Volume 8, Issue 4, pp 421–426 | Cite as

Validation of Bioanalytical Methods

  • H. Thomas Karnes
  • Gerald Shiu
  • Vinod P. Shah
Article

Abstract

Validation of bioanalytical methods used to generate data for pharmacokinetic and bioavailability studies is approached by a variety of techniques and is subject to many different methods of interpretation. This Review puts the various techniques into perspective and discusses pitfalls which may occur in interpretation of validation data. Recovery studies, standardization techniques, and selectivity/specificity are discussed with regard to the intrinsic value of various techniques that are used in validation. Models used for analytical calibration curves are explained in terms of their validity and limitations, along with a presentation of the most common ways to validate the model. Analytical sensitivity and detection limits are presented and discussed with regard to the usefulness of the various definitions. Appropriate means of testing precision and accuracy, the most important factors in assessing method quality, are presented. Stability and ruggedness testing are discussed along with a presentation of ways to assess data acceptability on a daily run basis.

quality control quality assurance validation calibration precision accuracy 

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Copyright information

© Plenum Publishing Corporation 1991

Authors and Affiliations

  • H. Thomas Karnes
    • 1
  • Gerald Shiu
    • 2
  • Vinod P. Shah
    • 2
  1. 1.Department of Pharmacy and PharmaceuticsVirginia Commonwealth UniversityRichmond
  2. 2.Food and Drug AdministrationCenter for Drug Evaluation and ResearchRockville20857

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