Guidelines for the Quality Control of Population Pharmacokinetic–Pharmacodynamic Analyses: an Industry Perspective
Journal Title: The AAPS Journal - Year 2012, Vol 14, Issue 4
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.
Authors and Affiliations
P. L. Bonate, A. Strougo, A. Desai, M. Roy, A. Yassen, J. S. van der Walt, A. Kaibara, S. Tannenbaum
Keywords
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