Aleksandra GALETIN   SITE

  • Clin Pharmacol Ther. 2021;110:1389-1400. Quantitative proteomic map of enzymes and transporters in the human kidney: stepping closer to mechanistic kidney models to define local kinetics. Al-Majdoub ZM, Scotcher D, Achour B, Barber J, Galetin A, Rostami-Hodjegan A. PubMed
  • Clin Pharmacol Ther. 2021;In press. Model-based drug-drug interaction extrapolation strategy from adults to children: Risdiplam in pediatric patients with spinal muscular atrophy. Cleary Y, Gertz M, Grimsey P, Günther A, Heinig K, Ogungbenro K, Aarons L, Galetin A, Kletzl H. PubMed
  • Mol Pharm. 2021;18:2997-3009. Physiologically based pharmacokinetic modeling of transporter-mediated hepatic disposition of imaging biomarker Gadoxetate in rats. Scotcher D, Melillo N, Tadimalla S, Darwich AS, Ziemian S, Ogungbenro K, Schütz G, Sourbron S, Galetin A. PubMed
  • Eur J Pharm Sci. 2021;165:105932. Reduced physiologically-based pharmacokinetic model of dabigatran etexilate-dabigatran and its application for prediction of intestinal P-gp-mediated drug-drug interactions. Lang J, Vincent L, Chenel M, Ogungbenro K, Galetin A. PubMed
  • Clin Pharmacokinet. 2021;60:1187-1199. Clinical investigation on endogenous biomarkers to predict strong OAT-mediated Drug-Drug Interactions. Willemin ME, Van Der Made TK, Pijpers I, Dillen L, Kunze A, Jonkers S, Steemans K, Tuytelaars A, Jacobs F, Monshouwer M, Scotcher D, Rostami-Hodjegan A, Galetin A, Snoeys. PubMed
  • CPT Pharmacometrics Syst Pharmacol. 2021;10:467-477. Population pharmacokinetic modelling and simulation to support qualification of pyridoxic acid as endogenous biomarker of OAT1/3 renal transporters. Ahmad A, Ogungbenro K, Kunze A, Jacobs F, Snoeys J, Rostami-Hodjegan A, Galetin A. PubMed
  • CPT Pharmacometrics Syst Pharmacol. 2021;10:137-147. PBPK model of Coproporphyrin I: Evaluation of the impact of SLCO1B1 genotype, ethnicity, and sex on its inter-individual variability. Takita H, Barnett S, Zhang Y, Ménochet K, Shen H, Ogungbenro K, Galetin A. PubMed
  • CPT Pharmacometrics Syst Pharmacol. 2020;9:695-706 Physiologically-based Pharmacokinetic Modelling of Creatinine-drug interactions in the Chronic Kidney Disease Population. Takita H, Scotcher D, Chinnadurai R, Kalra PA, Galetin A. PubMed
  • Clin Pharmacol Ther. 2021;109:55-64. Intestinal P-gp and putative hepatic OATP1B induction: ITC perspective on drug development implications. Zamek-Gliszczynski MJ, Patel M, Yang X, Lutz JD, Chu X, Brouwer KLR, Lai Y, Lee CA, Neuhoff S, Paine MF, Sugiyama Y, Taskar KS, Galetin A. PubMed
  • CPT Pharmacometrics Syst Pharmacol. 2020;9:310-321. A novel physiologically based model of creatinine renal disposition to integrate current knowledge of systems parameters and clinical observations. Scotcher D, Arya V, Yang X, Zhao P, Zhang L, Huang SM, Rostami-Hodjegan A, Galetin A. PubMed
  • CPT Pharmacometrics Syst Pharmacol. 2020;9:282-293. Mechanistic models as framework for understanding biomarker disposition: Prediction of creatinine-drug interactions. Scotcher D, Arya V, Yang X, Zhao P, Zhang L, Huang SM, Rostami-Hodjegan A, Galetin A.  PubMed
  • Mol Pharm. 2019;16:4551-4562. Quantitative translation of microfluidic transporter in vitro data to in vivo reveals impaired albumin-facilitated Indoxyl Sulfate secretion in Chronic Kidney Disease. van der Made TK, Fedecostante M, Scotcher D, Rostami-Hodjegan A, Sastre Toraño J, Middel I, Koster AS, Gerritsen KG, Jankowski V4, Jankowski J, Hoenderop JGJ, Masereeuw R, Galetin A. PubMed
  • Eur J Clin Pharmacol. 2019;75:1227-1235. A population pharmacokinetic model for simvastatin and its metabolites in children and adolescents. Ogungbenro K, Wagner JB, Abdel-Rahman S, Leeder JS, Galetin A. PubMed
  • Drug Metab Dispos. 2019;47:215-226. Hepatic Organic Anion Transporting Polypeptide-mediated clearance in the Beagle Dog: Assessing in vitro-in vivo relationships and applying cross-species empirical Scaling factors to improve prediction of human clearance. Matsunaga N, Ufuk A, Morse BL, Bedwell DW, Bao J, Mohutsky MA, Hillgren KM, Hall SD, Houston JB, Galetin A. PubMed
  • J Pharmacol Exp Ther. 2019;368:157-168. Towards further verification of Physiologically-Based Kidney Models: Predictability of the effects of urine-flow and urine-pH on renal clearance. Matsuzaki T, Scotcher D, Darwich A, Galetin A, Rostami-Hodjegan A. PubMed
  • Clin Pharmacol Ther. 2018;104:836-864. Clinical probes and endogenous biomarkers as substrates for transporter drug-drug interaction evaluation: Perspectives rom the International Transporter Consortium. Chu X, Liao M, Shen H, Yoshida K, Zur AA, Arya V, Galetin A, Giacomini KM, Hanna I, Kusuhara H, Lai Y, Rodrigues D, Sugiyama Y, Zamek-Gliszczynski MJ, Zhang L; International Transporter Consortium. PubMed
  • Clin Pharmacol Ther. 2018;104:788-792. Dabigatran Etexilate and Digoxin: Comparison as clinical probe substrates for evaluation of P-gp inhibition. Chu X, Galetin A, Zamek-Gliszczynski MJ, Zhang L, Tweedie DJ; International Transporter Consortium. PubMed
  • Clin Pharmacol Ther. 2018;in press. Use of Physiologically Based Pharmacokinetic modeling to evaluate the effect of chronic kidney disease on the disposition of hepatic CYP2C8 and OATP1B drug substrates. Tan ML, Zhao P, Zhang L, Ho YF, Varma MVS, Neuhoff S, Nolin TD, Galetin A, Huang SM. PubMed
  • Clin Pharmacol Ther. 2018;104:564-574. Gaining mechanistic insight into Coproporphyrin I as endogenous biomarker for OATP1B-mediated drug-drug interactions using population pharmacokinetic modeling and simulation. Barnett S, Ogungbenro K, Ménochet K, Shen H, Lai Y, Humphreys WG, Galetin A. PubMed
  • Clin Pharmacol Ther. 2018;104:865-889. Advancing predictions of tissue and intracellular drug concentrations using in vitro, imaging and physiologically based pharmacokinetic modeling approaches. Guo Y, Chu X, Parrott NJ, Brouwer KLR, Hsu V, Nagar S, Matsson P, Sharma P, Snoeys J, Sugiyama Y, Tatosian D, Unadkat JD, Huang SM, Galetin A; International Transporter Consortium. PubMed
  • J Pharmacol Exp Ther. 2018;In press. Comprehensive evaluation of the utility of 20 endogenous molecules as biomarkers of OATP1B inhibition compared to rosuvastatin and coproporphyrin I. Barnett S, Ogungbenro K, Menochet K, Shen H, Humphreys GW, Galetin A. PubMed
  • Clin Pharmacol Ther. 2018;104:766-771. The International Transporter Consortium: Summarizing advances in the role of transporters in drug development. Giacomini KM, Galetin A, Huang SM. PubMed
  • Clin Pharmacol Ther. 2018;104:781-784. ITC Commentary on Metformin clinical drug-drug interaction study design that enables an efficacy- and safety-based dose adjustment decision. Zamek-Gliszczynski MJ, Chu X, Cook JA, Custodio JM, Galetin A, Giacomini KM, Lee CA, Paine MF, Ray AS, Ware JA, Wittwer MB, Zhang L; International Transporter Consortium. PubMed
  • Drug-induced liver toxicity. New York, NY: Humana Press, Inc. 2018;627-651. Noninvasive preclinical and clinical imaging of liver transporter function relevant to drug-induced liver injury. J. Gerry Kenna JG, Waterton JC, Baudy A, Galetin A, Hines CDG, Hockings P, Patel M, Scotcher D, Sourbron S, Sabina Ziemian S, Schuetz G. LINK
  • Drug Metab Dispos. 2018;46:989-1000. Predicting human clearance of Organic Anion Transporting Polypeptide substrates using Cynomolgus monkey: In vitro-in vivo scaling of hepatic uptake clearance. De Bruyn T, Ufuk A, Cantrill C, Kosa RE, Bi YA, Niosi M, Modi S, Rodrigues AD, Tremaine LM, Varma MVS, Galetin A, Houston JB. PubMed
  • Clin Pharmacol Ther. 2018;104:803-817. Influence of transporter polymorphisms on drug disposition and response: A perspective from the International Transporter Consortium. Yee SW, Brackman DJ, Ennis EA, Sugiyama Y, Kamdem LK, Blanchard R, Galetin A, Zhang L, Giacomini KM. PubMed
  • J Pharmacol Exp Ther. 2018;365:688-699. In vitro-in vivo extrapolation of OATP1B-mediated drug-drug interactions in Cynomolgus monkey. Ufuk A, Kosa RE, Gao H, Bi YA, Modi S, Gates D, Rodrigues AD, Tremaine LM, Varma MVS, Houston JB, Galetin A. PubMed
  • J Pharm Sci. 2017;106:2209-2213. In vitro-in vivo extrapolation of metabolism- and transporter-mediated drug-drug interactions: Overview of basic prediction methods.Yoshida K, Zhao P, Zhang L, Abernethy DR, Rekić D, Reynolds KS, Galetin A, Huang SM. PubMed
  • J Pharm Sci. 2017;106:2204-2208. Physiologically based pharmacokinetic modeling of drug transporters to facilitate individualized dose prediction. Galetin A, Zhao P, Huang SM. PubMed
  • Pharmacogenet Genomics. 2017;27:27-38.Modelling of atorvastatin pharmacokinetics and the identification of the effect of a BCRP polymorphism in the Japanese population. Tsamandouras N1, Guo Y, Wendling T, Hall S, Galetin A, Aarons L. PubMed  
  • Eur J Pharm Sci. 2017;96:626-642. IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes.Darwich AS, Margolskee A, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B. PubMed
  • Drug Metab Dispos. 2015;43:490-509. Breast cancer resistance protein (ABCG2) in clinical pharmacokinetics and drug interactions: practical recommendations for clinical victim and perpetrator drug-drug interaction study design. Lee CA, O'Connor MA, Ritchie TK, Galetin A, Cook JA, Ragueneau-Majlessi I, Ellens H, Feng B, Taub ME, Paine MF, Polli JW, Ware JA, Zamek-Gliszczynski MJ. PubMed
  • Drug Metab Dispos. 2015;43:424-32. Meta-analysis of expression of hepatic organic anion-transporting polypeptide (OATP) transporters in cellular systems relative to human liver tissue. Badée J, Achour B, Rostami-Hodjegan A, Galetin A. PubMed
  • Pharm Res. 2015;32:1864-83. Development and Application of a Mechanistic Pharmacokinetic Model for Simvastatin and its Active Metabolite Simvastatin Acid Using an Integrated Population PBPK Approach. Tsamandouras N, Dickinson G, Guo Y, Hall S, Rostami-Hodjegan A, Galetin A, Aarons L. PubMed
  • Clin Pharmacol Ther. 2014;96:298-301. ITC commentary on the prediction of digoxin clinical drug-drug interactions from in vitro transporter assays. Lee CA, Kalvass JC, Galetin A, Zamek-Gliszczynski MJ. PubMed
  • Pharm Res. 2014;31:2367-82. Reduced physiologically-based pharmacokinetic model of repaglinide: impact of OATP1B1 and CYP2C8 genotype and source of in vitro data on the prediction of drug-drug interaction risk. Gertz M, Tsamandouras N, Säll C, Houston JB, Galetin A. PubMed
  • Methods Mol Biol. 2014;1113:255-88. Rationalizing underprediction of drug clearance from enzyme and transporter kinetic data: from in vitro tools to mechanistic modeling. Galetin A. PubMed
  • Drug Metab Dispos. 2014;42:650-64. Understanding the transport properties of metabolites: case studies and considerations for drug development. Zamek-Gliszczynski MJ, Chu X, Polli JW, Paine MF, Galetin A. PubMed
  • Clin Pharmacol Ther. 2013;94126-41.  Intracellular drug concentrations and transporters: measurement, modeling, and implications for the liver. Chu X, Korzekwa K, Elsby R, Fenner K, Galetin A, Lai Y, Matsson P, Moss A, Nagar S, Rosania GR, Bai JP, Polli JW, Sugiyama Y, Brouwer KL; International Transporter Consortium. PubMed
  • Clin Pharmacol Ther. 2013;94:64-79. ITC recommendations for transporter kinetic parameter estimation and translational modeling of transport-mediated PK and DDIs in humans. Zamek-Gliszczynski MJ, Lee CA, Poirier A, Bentz J, Chu X, Ellens H, Ishikawa T, Jamei M, Kalvass JC, Nagar S, Pang KS, Korzekwa K, Swaan PW, Taub ME, Zhao P, Galetin A; International Transporter Consortium. PubMed
  • Pharm Res. 2013;30:761-80. Cyclosporine inhibition of hepatic and intestinal CYP3A4, uptake and efflux transporters: application of PBPK modeling in the assessment of drug-drug interaction potential. Gertz M, Cartwright CM, Hobbs MJ, Kenworthy KE, Rowland M, Houston JB, Galetin A. PubMed
  • Drug Metab Dispos. 2012;40:1744-56. Use of mechanistic modeling to assess interindividual variability and interspecies differences in active uptake in human and rat hepatocytes. Ménochet K, Kenworthy KE, Houston JB, Galetin A. PubMed
  • Drug Metab Dispos. 2012;40:1007-17. Mechanistic pharmacokinetic modeling for the prediction of transporter-mediated disposition in humans from sandwich culture human hepatocyte data. Jones HM, Barton HA, Lai Y, Bi YA, Kimoto E, Kempshall S, Tate SC, El-Kattan A, Houston JB, Galetin A, Fenner KS. PubMed
  • J Pharmacol Exp Ther. 2012;341:2-15. Simultaneous assessment of uptake and metabolism in rat hepatocytes: a comprehensive mechanistic model. Ménochet K, Kenworthy KE, Houston JB, Galetin A. PubMed

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Last update: October 2021