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

• Published in: The AAPS journal Vol. 14; no. 4; pp. 749 - 758
• Main Authors: Bonate, P. L., Strougo, A., Desai, A., Roy, M., Yassen, A., van der Walt, J. S., Kaibara, A., Tannenbaum, S.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.12.2012
• Subjects: Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Drug Design; Drug Industry - methods; Guidelines as Topic; Humans; Models, Biological; Nonlinear Dynamics; Pharmacology/Toxicology; Pharmacy; Quality Control; Review; Review Article; quality assurance; modeling; NONMEM
• ISSN: 1550-7416; 1550-7416
• DOI: 10.1208/s12248-012-9387-9

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.