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The AAPS Journal

, Volume 14, Issue 4, pp 749–758 | Cite as

Guidelines for the Quality Control of Population Pharmacokinetic–Pharmacodynamic Analyses: an Industry Perspective

  • P. L. BonateEmail author
  • A. Strougo
  • A. Desai
  • M. Roy
  • A. Yassen
  • J. S. van der Walt
  • A. Kaibara
  • S. Tannenbaum
Review Article

Abstract

Quality population modeling and simulation analyses and reports are something every modeler desires. However, little attention in the literature has been paid to what constitutes quality regarding population analyses. Very rarely do published manuscripts contain any statement about quality assurance of the modeling results contained therein. The purpose of this manuscript is to present guidelines for the quality assurance of population analyses, particularly with regards to the use of NONMEM from an industrial perspective. Quality guidelines are developed for the NONMEM installation itself, NONMEM data sets, control streams, output listings, output data files and resultant post-processing, reporting of results, and the review processes. These guidelines were developed to be thorough yet practical, though are not meant to be completely comprehensive. It is our desire to ensure that what is reported accurately reflects the collected data, the modeling process, and model outputs for a modeling project.

Key words

modeling NONMEM quality assurance 

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Copyright information

© American Association of Pharmaceutical Scientists 2012

Authors and Affiliations

  • P. L. Bonate
    • 1
    Email author
  • A. Strougo
    • 2
  • A. Desai
    • 1
  • M. Roy
    • 1
  • A. Yassen
    • 2
  • J. S. van der Walt
    • 2
  • A. Kaibara
    • 3
  • S. Tannenbaum
    • 1
  1. 1.Astellas Pharma Global DevelopmentNorthbrookUSA
  2. 2.Astellas Pharma Global DevelopmentLeiderdorpThe Netherlands
  3. 3.Astellas Pharm IncItabashi-ku, TokyoJapan

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