Works by Gueorguieva, Ivelina

Results: 35

IQ Survey Results on Current Industry Practices: Part 2—Quantitative Evaluations of Immunogenicity Assessment.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 6, p. 1605, doi. 10.1002/cpt.3573

By:

Richards, Susan;
Winzenborg, Insa;
Luedtke, Doreen;
Niu, Tao;
Hamuro, Lora;
Kowalski, Karey;
Leu, Jocelyn H.;
Yang, Jianning;
Ganti, Vaishnavi;
Bhattacharya, Indranil;
Gueorguieva, Ivelina;
Mostafa, Nael;
Grimaldi, Christine;
Wu, Benjamin

Publication type:

Article

Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction.

Published in:

Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2025, v. 21, n. 4, p. 1, doi. 10.1002/alz.70062

By:

Wang, Hong;
Serap Monkul Nery, Emel;
Ardayfio, Paul;
Khanna, Rashna;
Otero Svaldi, Diana;
Gueorguieva, Ivelina;
Shcherbinin, Sergey;
Andersen, Scott W.;
Hauck, Paula M.;
Engle, Staci E.;
Brooks, Dawn A.;
Collins, Emily C.;
Fox, Nick C.;
Greenberg, Steven M.;
Salloway, Stephen;
Mintun, Mark A.;
Sims, John R.

Publication type:

Article

Association of Amyloid Reduction After Donanemab Treatment With Tau Pathology and Clinical Outcomes: The TRAILBLAZER-ALZ Randomized Clinical Trial.

Published in:

JAMA Neurology, 2022, v. 79, n. 10, p. 1015, doi. 10.1001/jamaneurol.2022.2793

By:

Shcherbinin, Sergey;
Evans, Cynthia D.;
Lu, Ming;
Andersen, Scott W.;
Pontecorvo, Michael J.;
Willis, Brian A.;
Gueorguieva, Ivelina;
Hauck, Paula M.;
Brooks, Dawn A.;
Mintun, Mark A.;
Sims, John R.

Publication type:

Article

Galunisertib plus gemcitabine vs. gemcitabine for first-line treatment of patients with unresectable pancreatic cancer.

Published in:

2018

By:

Melisi, Davide;
Garcia-Carbonero, Rocio;
Macarulla, Teresa;
Pezet, Denis;
Deplanque, Gael;
Fuchs, Martin;
Trojan, Jorg;
Oettle, Helmut;
Kozloff, Mark;
Cleverly, Ann;
Smith, Claire;
Estrem, Shawn T.;
Gueorguieva, Ivelina;
Lahn, Michael M. F.;
Blunt, Al;
Benhadji, Karim A.;
Tabernero, Josep

Publication type:

journal article

Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma.

Published in:

Liver International, 2019, v. 39, n. 8, p. 1468, doi. 10.1111/liv.14113

By:

Faivre, Sandrine;
Santoro, Armando;
Kelley, Robin K.;
Gane, Ed;
Costentin, Charlotte E.;
Gueorguieva, Ivelina;
Smith, Claire;
Cleverly, Ann;
Lahn, Michael M.;
Raymond, Eric;
Benhadji, Karim A.;
Giannelli, Gianluigi

Publication type:

Article

A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma.

Published in:

Neuro-Oncology, 2016, v. 18, n. 8, p. 1146, doi. 10.1093/neuonc/now009

By:

Brandes, Alba A.;
Carpentier, Antoine F.;
Kesari, Santosh;
Sepulveda-Sanchez, Juan M.;
Wheeler, Helen R.;
Chinot, Olivier;
Cher, Lawrence;
Steinbach, Joachim P.;
Capper, David;
Specenier, Pol;
Rodon, Jordi;
Cleverly, Ann;
Smith, Claire;
Gueorguieva, Ivelina;
Miles, Colin;
Guba, Susan C.;
Desaiah, Durisala;
Lahn, Michael M.;
Wick, Wolfgang

Publication type:

Article

A phase Ib/II study of galunisertib in combination with nivolumab in solid tumors and non-small cell lung cancer.

Published in:

BMC Cancer, 2023, v. 23, n. 1, p. 1, doi. 10.1186/s12885-023-11153-1

By:

Nadal, Ernest;
Saleh, Mansoor;
Aix, Santiago Ponce;
Ochoa-de-Olza, Maria;
Patel, Sandip Pravin;
Antonia, Scott;
Zhao, Yumin;
Gueorguieva, Ivelina;
Man, Michael;
Estrem, Shawn T.;
Liu, Jiangang;
Avsar, Emin;
Lin, Wen Hong;
Benhadji, Karim A.;
Gandhi, Leena;
Guba, Susan C.;
Diaz, Inmaculada Ales

Publication type:

Article

Quantifying natural amyloid plaque accumulation in the continuum of Alzheimer’s disease using ADNI.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2025, v. 52, n. 1, p. 1, doi. 10.1007/s10928-024-09959-y

By:

Elhefnawy, Marwa E.;
Patson, Noel;
Mouksassi, Samer;
Pillai, Goonaseelan;
Shcherbinin, Sergey;
Chigutsa, Emmanuel;
Gueorguieva, Ivelina

Publication type:

Article

Population pharmacokinetic modelling of S-warfarin to evaluate the design of drug-drug interaction studies for CYP2C9.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2012, v. 39, n. 2, p. 147, doi. 10.1007/s10928-011-9235-z

By:

Klein, Kerenaftali;
Gueorguieva, Ivelina;
Aarons, Leon

Publication type:

Article

Ethnic differences in the population pharmacokinetics and pharmacodynamics of warfarin.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2010, v. 37, n. 1, p. 3

By:

Ivelina Gueorguieva;
Stephen Wise;
Danny Soon;
Leon Aarons

Publication type:

Article

Optimal Design for Multiresponse Pharmacokinetic–Pharmacodynamic Models – Dealing with Unbalanced Designs.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2007, v. 34, n. 3, p. 313, doi. 10.1007/s10928-006-9048-7

By:

Kayode Ogungbenro;
Ivelina Gueorguieva;
Oneeb Majid;
Gordon Graham;
Leon Aarons

Publication type:

Article

Population pharmacokinetics and exposure-overall survival analysis of the transforming growth factor-β inhibitor galunisertib in patients with pancreatic cancer.

Published in:

2019

By:

Gueorguieva, Ivelina;
Tabernero, Josep;
Melisi, Davide;
Macarulla, Teresa;
Merz, Valeria;
Waterhouse, Timothy H.;
Miles, Colin;
Lahn, Michael M.;
Cleverly, Ann;
Benhadji, Karim A.

Publication type:

journal article

A phase 1 study of anti-TGFβ receptor type-II monoclonal antibody LY3022859 in patients with advanced solid tumors.

Published in:

2017

By:

Tolcher, Anthony;
Berlin, Jordan;
Cosaert, Jan;
Kauh, John;
Chan, Emily;
Piha-Paul, Sarina;
Amaya, Alex;
Tang, Shande;
Driscoll, Kyla;
Kimbung, Richard;
Kambhampati, S.;
Gueorguieva, Ivelina;
Hong, David;
Tolcher, Anthony W;
Berlin, Jordan D;
Piha-Paul, Sarina A;
Kambhampati, S R Prasad;
Hong, David S

Publication type:

journal article

Phase 1 study of galunisertib, a TGF-beta receptor I kinase inhibitor, in Japanese patients with advanced solid tumors.

Published in:

2015

By:

Fujiwara, Yutaka;
Nokihara, Hiroshi;
Yamada, Yasuhide;
Yamamoto, Noboru;
Sunami, Kuniko;
Utsumi, Hirofumi;
Asou, Hiroya;
TakahashI, Osamu;
Ogasawara, Ken;
Gueorguieva, Ivelina;
Tamura, Tomohide

Publication type:

journal article

Incorporating Correlation in Interindividual Variability for the Optimal Design of Multiresponse Pharmacokinetic Experiments.

Published in:

Journal of Biopharmaceutical Statistics, 2008, v. 18, n. 2, p. 342, doi. 10.1080/10543400701697208

By:

Ogungbenro, Kayode;
Graham, Gordon;
Gueorguieva, Ivelina;
Aarons, Leon

Publication type:

Article

Phase 1b study of galunisertib and ramucirumab in patients with advanced hepatocellular carcinoma.

Published in:

Cancer Medicine, 2021, v. 10, n. 9, p. 3059, doi. 10.1002/cam4.3880

By:

Harding, James J.;
Do, Richard K.;
Yaqubie, Amin;
Cleverly, Ann;
Zhao, Yumin;
Gueorguieva, Ivelina;
Lahn, Michael;
Benhadji, Karim A.;
Kelley, Robin K.;
Abou‐Alfa, Ghassan K.

Publication type:

Article

Models for change in tumour size, appearance of new lesions and survival probability in patients with advanced epithelial ovarian cancer.

Published in:

British Journal of Clinical Pharmacology, 2016, v. 82, n. 3, p. 717, doi. 10.1111/bcp.12994

By:

Zecchin, Chiara;
Gueorguieva, Ivelina;
Enas, Nathan H.;
Friberg, Lena E.

Publication type:

Article

Defining a therapeutic window for the novel TGF-β inhibitor LY2157299 monohydrate based on a pharmacokinetic/pharmacodynamic model.

Published in:

British Journal of Clinical Pharmacology, 2014, v. 77, n. 5, p. 796, doi. 10.1111/bcp.12256

By:

Gueorguieva, Ivelina;
Cleverly, Ann L.;
Stauber, Anja;
Pillay, N. Sada;
Rodon, Jordi A.;
Miles, Colin P.;
Yingling, Jonathan M.;
Lahn, Michael M.

Publication type:

Article

Desipramine, substrate for CYP2D6 activity: population pharmacokinetic model and design elements of drug-drug interaction trials.

Published in:

British Journal of Clinical Pharmacology, 2010, v. 70, n. 4, p. 523, doi. 10.1111/j.1365-2125.2010.03731.x

By:

Gueorguieva, Ivelina;
Jackson, Kimberley;
Wrighton, Steven A.;
Sinha, Vikram P.;
Chien, Jenny Y.

Publication type:

Article

Pharmacokinetic modelling of interleukin-1 receptor antagonist in plasma and cerebrospinal fluid of patients following subarachnoid haemorrhage.

Published in:

British Journal of Clinical Pharmacology, 2008, v. 65, n. 3, p. 317, doi. 10.1111/j.1365-2125.2007.03026.x

By:

Gueorguieva, Ivelina;
Clark, Simon R.;
McMahon, Catherine J.;
Scarth, Sylvia;
Rothwell, Nancy J.;
Tyrell, Pippa J.;
Hopkins, Stephen J.;
Rowland, Malcolm

Publication type:

Article

Handling Missing Data in a Duloxetine Population Pharmacokinetic/Pharmacodynamic Model - Imputation Methods and Selection Models.

Published in:

Pharmaceutical Research, 2014, v. 31, n. 10, p. 2829, doi. 10.1007/s11095-014-1380-9

By:

Yuen, Eunice;
Gueorguieva, Ivelina;
Aarons, Leon

Publication type:

Article

Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease.

Published in:

Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 6, p. 1258, doi. 10.1002/cpt.2875

By:

Gueorguieva, Ivelina;
Willis, Brian A.;
Chua, Laiyi;
Chow, Kay;
Ernest, C. Steven;
Shcherbinin, Sergey;
Ardayfio, Paul;
Mullins, Garrett R.;
Sims, John R.

Publication type:

Article

Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine.

Published in:

International Journal of Molecular Sciences, 2017, v. 18, n. 5, p. 995, doi. 10.3390/ijms18050995

By:

Capper, David;
von Deimling, Andreas;
Brandes, Alba A.;
Carpentier, Antoine F.;
Kesari, Santosh;
Sepulveda-Sanchez, Juan M.;
Wheeler, Helen R.;
Chinot, Olivier;
Cher, Lawrence;
Steinbach, Joachim P.;
Specenier, Pol;
Rodon, Jordi;
Cleverly, Ann;
Smith, Claire;
Gueorguieva, Ivelina;
Miles, Colin;
Guba, Susan C.;
Desaiah, Durisala;
Estrem, Shawn T.;
Lahn, Michael M.

Publication type:

Article

Cardiac Safety of TGF-β Receptor I Kinase Inhibitor LY2157299 Monohydrate in Cancer Patients in a First-in-Human Dose Study.

Published in:

Cardiovascular Toxicology, 2015, v. 15, n. 4, p. 309, doi. 10.1007/s12012-014-9297-4

By:

Kovacs, Richard;
Maldonado, Giuliana;
Azaro, Analia;
Fernández, Maria;
Romero, Federico;
Sepulveda-Sánchez, Juan;
Corretti, Mary;
Carducci, Michael;
Dolan, Melda;
Gueorguieva, Ivelina;
Cleverly, Ann;
Pillay, N.;
Baselga, Jose;
Lahn, Michael

Publication type:

Article

Donanemab exposure and efficacy relationship using modeling in Alzheimer's disease.

Published in:

Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2023, v. 9, n. 2, p. 1, doi. 10.1002/trc2.12404

By:

Gueorguieva, Ivelina;
Willis, Brian A.;
Chua, Laiyi;
Chow, Kay;
Ernest, C. Steven;
Wang, Jian;
Shcherbinin, Sergey;
Sims, John R.;
Chigutsa, Emmanuel

Publication type:

Article

Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling.

Published in:

AAPS Journal, 2015, v. 17, n. 6, p. 1395, doi. 10.1208/s12248-015-9797-6

By:

Ding, Xuan;
Gueorguieva, Ivelina;
Wesley, James;
Burns, Lee;
Coutant, Carrie

Publication type:

Article

Amyloid re‐accumulation after donanemab treatment: summary from 3 interventional trials.

Published in:

Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2023, v. 19, p. 1, doi. 10.1002/alz.078175

By:

Shcherbinin, Sergey;
Gueorguieva, Ivelina;
Cheng, Yun‐Ju;
Evans, Cynthia D.;
Case, Michael G.;
Chidambaram, Swathi;
Collins, Emily C.;
Brooks, Dawn A.;
Sims, John R.;
Lu, Ming

Publication type:

Article

Donanemab exposure‐efficacy relationship in patients with early symptomatic Alzheimer's disease.

Published in:

Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2023, v. 19, p. 1, doi. 10.1002/alz.062599

By:

Gueorguieva, Ivelina;
Chua, Laiyi;
Chow, Kay Hoong;
Ernest, C Steven;
Willis, Brian A.;
Shcherbinin, Sergey;
Sims, John R.;
Chigutsa, Emmanuel

Publication type:

Article

Disease progression model using the integrated Alzheimer's Disease Rating Scale.

Published in:

Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2023, v. 19, n. 6, p. 2253, doi. 10.1002/alz.12876

By:

Gueorguieva, Ivelina;
Chua, Laiyi;
Willis, Brian A.;
Sims, John R.;
Wessels, Alette M.

Publication type:

Article

Linking preclinical and clinical whole-body physiologically based pharmacokinetic models with prior distributions in NONMEM.

Published in:

European Journal of Clinical Pharmacology, 2007, v. 63, n. 5, p. 485, doi. 10.1007/s00228-007-0264-x

By:

Langdon, Grant;
Gueorguieva, Ivelina;
Aarons, Leon;
Karlsson, Mats

Publication type:

Article

Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy in patients with newly diagnosed malignant glioma.

Published in:

Investigational New Drugs, 2020, v. 38, n. 5, p. 1570, doi. 10.1007/s10637-020-00910-9

By:

Wick, Antje;
Desjardins, Annick;
Suarez, Cristina;
Forsyth, Peter;
Gueorguieva, Ivelina;
Burkholder, Tiana;
Cleverly, Ann Louise;
Estrem, Shawn T.;
Wang, Shuaicheng;
Lahn, Michael M.;
Guba, Susan C.;
Capper, David;
Rodon, Jordi

Publication type:

Article

Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer.

Published in:

2015

By:

Rodón, Jordi;
Carducci, Michael;
Sepulveda-Sánchez, Juan;
Azaro, Analía;
Calvo, Emiliano;
Seoane, Joan;
Braña, Irene;
Sicart, Elisabet;
Gueorguieva, Ivelina;
Cleverly, Ann;
Pillay, N.;
Desaiah, Durisala;
Estrem, Shawn;
Paz-Ares, Luis;
Holdhoff, Matthias;
Blakeley, Jaishri;
Lahn, Michael;
Baselga, Jose

Publication type:

Journal Article

Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer.

Published in:

Investigational New Drugs, 2015, v. 33, n. 2, p. 357, doi. 10.1007/s10637-014-0192-4

By:

Rodón, Jordi;
Carducci, Michael;
Sepulveda-Sánchez, Juan;
Azaro, Analía;
Calvo, Emiliano;
Seoane, Joan;
Braña, Irene;
Sicart, Elisabet;
Gueorguieva, Ivelina;
Cleverly, Ann;
Pillay, N.;
Desaiah, Durisala;
Estrem, Shawn;
Paz-Ares, Luis;
Holdhoff, Matthias;
Blakeley, Jaishri;
Lahn, Michael;
Baselga, Jose

Publication type:

Article

Clinical development of galunisertib (LY2157299 monohydrate), a small molecule inhibitor of transforming growth factor-beta signaling pathway.

Published in:

Drug Design, Development & Therapy, 2015, v. 9, p. 4479, doi. 10.2147/DDDT.S86621

By:

Herbertz, Stephan;
Sawyer, J. Scott;
Stauber, Anja J.;
Gueorguieva, Ivelina;
Driscol, Kyla E.;
Estrem, Shawn T.;
Cleverly, Ann L.;
Desaiah, Durisala;
Guba, Susan C.;
Benhadji, Karim A.;
Slapak, Christopher A.;
Lahn, Michael M.

Publication type:

Article

Disposition and metabolism of [ C]-galunisertib, a TGF- β RI kinase/ALK5 inhibitor, following oral administration in healthy subjects and mechanistic prediction of the effect of itraconazole on galunisertib pharmacokinetics.

Published in:

Xenobiotica, 2018, v. 48, n. 4, p. 382, doi. 10.1080/00498254.2017.1323137

By:

Cassidy, Kenneth C.;
Gueorguieva, Ivelina;
Miles, Colin;
Rehmel, Jessica;
Yi, Ping;
Ehlhardt, William J.

Publication type:

Article