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

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...