Expertise in population pharmacokinetics, pharmacokinetic-pharmacodynamic and exposure-response modelling and simulation in a variety of therapeutic areas
We assist our clients to prepare high quality quantitative clinical pharmacology modelling and simulation reports to support submissions to pharmaceutical regulators.
Principal consultant, Helen Kastrissios, PhD, is a pharmacometrician with over 20 years of experience in applying quantitative clinical pharmacology methods to support regulatory submissions.
Kazutaka Y, Kobayashi Y, Endo S, Fukae M, Hennig S, Kastrissios H, Kamiyama E, Garimella T, Abutarif M. Trastuzumab Deruxtecan Dosing in Human Epidermal Growth Factor Receptor 2-Positive Gastric Cancer: Population Pharmacokinetic Modeling and Exposure-Response Analysis. J Clin. Pharmacol. 2023; 63 (11):1232-1243
Kazutaka Y, Fukae M, Kastrissios H, Wada R, Shimizu T, Ishizuka H. Population pharmacokinetics of esaxerenone, a novel non-steroidal mineralocorticoid receptor blocker, in patients with essential hypertension, patients with diabetic nephropathy, and healthy volunteers. Drug Metab Pharmacokin. 2023; 52(100516):1-11
Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici M. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. British J. Clin. Pharmacol. 2021; 87(6):2558 – 2571
Dykstra K, Mehrotra N, Tornøe CW, Kastrissios H, Patel B, Al-Huniti N, Jadhav P, Wang Y, Byon W. Reporting guidelines for population pharmacokinetic analyses. J. Pharmacokinet. Pharmacodyn. 2015; 42(3):301-14