I. Gueorguieva

J. Salles, A. Rothenbuhler, A. Linglart, 2017, Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society.

Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA)

Joon-Oh Park, R. Greil, E. Van Cutsem, 2021, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Ethnic differences in the population pharmacokinetics and pharmacodynamics of warfarin

L. Aarons, I. Gueorguieva, S. Wise, 2010, Journal of Pharmacokinetics and Pharmacodynamics.

Case Series of Cancer Patients Treated With Galunisertib, a Transforming Growth Factor-Beta Receptor I Kinase Inhibitor in a First-in-Human Dose Study

M. Carducci, M. Holdhoff, A. Cleverly, 2014 .

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

N. Enas, Chiara Zecchin, L. Friberg, 2016, British journal of clinical pharmacology.

Phase Ib study evaluating safety and pharmacokinetics (PK) of the oral transforming growth factor-beta (TGF-ß) receptor I kinase inhibitor LY2157299 monohydrate (LY) when combined with gemcitabine in patients with advanced cancer.

J. Tabernero, A. Cleverly, T. Macarulla, 2013 .

Demographic Characteristics, Risk Factors, and Presenting Features of Children with Symptomatic Nutritional Rickets: A French Series

J. Salles, J. Bacchetta, A. Rothenbuhler, 2020, Hormone Research in Paediatrics.

Phase II Study of the ALK5 Inhibitor Galunisertib in Very Low-, Low-, and Intermediate-Risk Myelodysplastic Syndromes

K. Pradhan, A. Verma, U. Steidl, 2019, Clinical Cancer Research.

Relative bioavailability of three formulations of galunisertib administered as monotherapy in patients with advanced or metastatic cancer

J. Seoane, I. Braña, M. Mitchell, 2016, Drugs in context.

Association of Amyloid Reduction After Donanemab Treatment With Tau Pathology and Clinical Outcomes

M. Mintun, M. Pontecorvo, P. Hauck, 2022, JAMA neurology.

Near normalization of adult height and body proportions by growth hormone in pycnodysostosis.

P. Bougnères, N. Lahlou, A. Linglart, 2010, The Journal of clinical endocrinology and metabolism.

Defining a therapeutic window for the novel TGFâ•’Î2 inhibitor LY2157299 monohydrate based on a pharmacokinetic/pharmacodynamic model

J. Yingling, A. Cleverly, I. Gueorguieva, 2014 .

A phase Ib dose-escalation and cohort-expansion study of safety and activity of the transforming growth factor (TGF) β receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer.

Joon-Oh Park, A. Varghese, D. Melisi, 2019, Journal of Clinical Oncology.

A phase 2 study of galunisertib, a novel transforming growth factor-beta (TGF-β) receptor I kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC) and low serum alpha fetoprotein (AFP).

G. Giannelli, E. Raymond, A. Santoro, 2016 .

Disposition and metabolism of [14C]-galunisertib, a TGF-βRI kinase/ALK5 inhibitor, following oral administration in healthy subjects and mechanistic prediction of the effect of itraconazole on galunisertib pharmacokinetics

K. Cassidy, P. Yi, J. Rehmel, 2018, Xenobiotica; the fate of foreign compounds in biological systems.

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

L. Aarons, I. Gueorguieva, E. Yuen, 2014, Pharmaceutical Research.

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

K. Klein, L. Aarons, I. Gueorguieva, 2012, Journal of Pharmacokinetics and Pharmacodynamics.

Integrated data review of the first-in-human dose (FHD) study evaluating safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the oral transforming growth factor-beta (TGF-ß) receptor I kinase inhibitor, LY2157299 monohydrate (LY).

J. Baselga, J. Seoane, M. Carducci, 2013 .

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

Leon Aarons, Kayode Ogungbenro, Ivelina Gueorguieva, 2008, Journal of biopharmaceutical statistics.

A program for individual and population optimal design for univariate and multivariate response pharmacokinetic-pharmacodynamic models

Gordon Graham, Leon Aarons, Kayode Ogungbenro, 2007, Comput. Methods Programs Biomed..

A program for the optimum design of pharmacokinetic, pharmacodynamic, drug metabolism and drug-drug interaction models

Gordon Graham, Ivelina Gueorguieva, Kelly Dickens, 2005, Comput. Methods Programs Biomed..

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

S. Estrem, C. Slapak, A. Cleverly, 2015, Drug design, development and therapy.

Mechanism for enhanced absorption of a solid dispersion formulation of LY2300559 using the artificial stomach duodenum model.

Christopher S. Polster, I. Gueorguieva, David C. Sperry, 2015, Molecular pharmaceutics.

Interleukin-1 Receptor Antagonist Penetrates Human Brain at Experimentally Therapeutic Concentrations

N. Rothwell, M. Rowland, P. Tyrrell, 2008, Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism.

First-in-Human Dose Study of the Novel Transforming Growth Factor-β Receptor I Kinase Inhibitor LY2157299 Monohydrate in Patients with Advanced Cancer and Glioma

J. Baselga, J. Seoane, M. Carducci, 2014, Clinical Cancer Research.

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

D. Capper, A. Wick, S. Estrem, 2020, Investigational New Drugs.

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

Ivelina Gueorguieva, J. Yingling, A. Cleverly, 2014, British journal of clinical pharmacology.

Clinical development of galunisertib ( LY 2157299 monohydrate ) , a small molecule inhibitor of transforming growth factorbeta factorbeta factorbeta signaling pathway

S. Estrem, C. Slapak, A. Cleverly, 2015 .

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

H. Utsumi, T. Tamura, K. Ogasawara, 2015, Cancer Chemotherapy and Pharmacology.

Molecular analysis of WNT4 gene in four adolescent girls with mullerian duct abnormality and hyperandrogenism (atypical Mayer-Rokitansky-Küster-Hauser syndrome).

P. Philibert, C. Sultan, C. Pienkowski, 2011, Fertility and sterility.

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

A. Brandes, A. von Deimling, O. Chinot, 2017, International journal of molecular sciences.

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

J. Baselga, J. Seoane, M. Carducci, 2014, Investigational New Drugs.

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

J. Tabernero, J. Trojan, H. Oettle, 2018, British Journal of Cancer.

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

G. Abou-Alfa, J. Harding, R. Do, 2021, Cancer medicine.

Investigating the impact of target lesion selection on drug effect evaluation and tumour growth rate determination using tumour growth inhibition models: example of malignant pleural mesothelioma patients treated with cisplatin alone or in combination with pemetrexed.

L. Aarons, H. Mistry, K. Ogungbenro, 2021, European Journal of Pharmaceutical Sciences.

A Phase 2 Study of Galunisertib (TGF-β1 Receptor Type I Inhibitor) and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

P. Galle, G. Giannelli, R. Kelley, 2019, Clinical and translational gastroenterology.

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

J. Tabernero, D. Melisi, A. Cleverly, 2019, Cancer Chemotherapy and Pharmacology.

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

J. Baselga, R. Kovacs, M. Corretti, 2014, Cardiovascular Toxicology.

A Review of Mixed-Effects Models of Tumor Growth and Effects of Anticancer Drug Treatment Used in Population Analysis

L E Friberg, N H Holford, P Magni, 2014, CPT: pharmacometrics & systems pharmacology.

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

J. Tabernero, J. Trojan, H. Oettle, 2018, British Journal of Cancer.

Welcome and session 1 : Mechanistic Modelling of Drug Absorption

L. Aarons, I. Gueorguieva, Sun Knutsson, 2009 .

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

N. Rothwell, M. Rowland, P. Tyrrell, 2008, British journal of clinical pharmacology.

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

G. Giannelli, E. Raymond, A. Santoro, 2019, Liver international : official journal of the International Association for the Study of the Liver.

Uncertainty Analysis in Pharmacokinetics and Pharmacodynamics: Application to Naratriptan

Malcolm Rowland, Leon Aarons, Ivelina Gueorguieva, 2005, Pharmaceutical Research.

The use of a modified Fedorov exchange algorithm to optimise sampling times for population pharmacokinetic experiments

Gordon Graham, Leon Aarons, Kayode Ogungbenro, 2005, Comput. Methods Programs Biomed..

Dramatic impact of morbid obesity on child lung development.

C. Monaca, R. Matran, O. Le Rouzic, 2021, Archives de pediatrie : organe officiel de la Societe francaise de pediatrie.

Early change in tumour size predicts overall survival in patients with first-line metastatic breast cancer.

B. Ribba, N. Enas, S. Tate, 2016, European journal of cancer.

A phase II, double-blind study of galunisertib+gemcitabine (GG) vs gemcitabine+placebo (GP) in patients (pts) with unresectable pancreatic cancer (PC).

J. Tabernero, J. Trojan, H. Oettle, 2016 .

Brief Report: Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination with Pegilodecakin in Patients with Metastatic Non-Small-Cell Lung Cancer (CYPRESS-1 and CYPRESS-2).

J. Nemunaitis, D. Ferry, L. Gandhi, 2020, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

O126 EVALUATION OF LY2157299 MONOHYDRATE (LY), A TGF-β RECEPTOR I KINASE INHIBITOR, IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA: PHASE 2 STUDY RESULTS OF SAFETY, EFFICACY AND PK/PD

G. Giannelli, E. Raymond, A. Santoro, 2014 .

Fuzzy Simulation of Pharmacokinetic Models: Case Study of Whole Body Physiologically Based Model of Diazepam

Malcolm Rowland, I. Nestorov, M. Rowland, 2004, Journal of Pharmacokinetics and Pharmacodynamics.

Reducing Whole Body Physiologically Based Pharmacokinetic Models Using Global Sensitivity Analysis: Diazepam Case Study

Malcolm Rowland, Ivelina Gueorguieva, I. Nestorov, 2006, Journal of Pharmacokinetics and Pharmacodynamics.

Incorporating measures of variability and uncertainty into the prediction of in vivo hepatic clearance from in vitro data.

Malcolm Rowland, Ivan Nestorov, Ivelina Gueorguieva, 2002, Drug metabolism and disposition: the biological fate of chemicals.

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

Carrie A. Coutant, James A. Wesley, Xuan Ding, 2015, The AAPS Journal.

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

C. Ernest, S. Shcherbinin, B. Willis, 2023, Clinical pharmacology and therapeutics.

Diazepam Pharamacokinetics from Preclinical to Phase I Using a Bayesian Population Physiologically Based Pharmacokinetic Model with Informative Prior Distributions in Winbugs

Ivelina Gueorguieva, Leon Aarons, Malcolm Rowland, 2006, Journal of Pharmacokinetics and Pharmacodynamics.

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

Leon Aarons, Ivelina Gueorguieva, Mats Karlsson, 2007, European Journal of Clinical Pharmacology.

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

J. Baselga, R. Kovacs, M. Corretti, 2014, Cardiovascular Toxicology.

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

C. Ernest, S. Shcherbinin, B. Willis, 2023, Alzheimer's & dementia.

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

A. Wessels, B. Willis, I. Gueorguieva, 2022, Alzheimer's & dementia : the journal of the Alzheimer's Association.

Donanemab (LY3002813) Phase 1b Study in Alzheimer’s Disease: Rapid and Sustained Reduction of Brain Amyloid Measured by Florbetapir F18 Imaging

A. Fleisher, J. Dage, S. Shcherbinin, 2021, The Journal of Prevention of Alzheimer's Disease.

The oral transforming growth factor-beta (TGF-ß) receptor I kinase inhibitor LY2157299 plus lomustine in patients with treatment-refractory malignant glioma: The first human dose study.

J. Baselga, J. Seoane, M. Carducci, 2012 .

First human dose (FHD) study of the oral transforming growth factor-beta receptor I kinase inhibitor LY2157299 in patients with treatment-refractory malignant glioma.

J. Baselga, J. Seoane, M. Carducci, 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

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

S. Estrem, Jiangang Liu, L. Gandhi, 2023, BMC Cancer.

Current Use and Developments Needed for Optimal Design in Pharmacometrics: A Study Performed Among DDMoRe's European Federation of Pharmaceutical Industries and Associations Members

M Lavielle, M O Karlsson, E Comets, 2013, CPT: pharmacometrics & systems pharmacology.

Development of a Whole Body Physiologically Based Model to Characterise the Pharmacokinetics of Benzodiazepines. 1: Estimation of Rat Tissue-Plasma Partition Ratios

I. Nestorov, M. Rowland, J. Duffy, 2004, Journal of Pharmacokinetics and Pharmacodynamics.

Association of environmental markers with childhood type 1 diabetes mellitus revealed by a long questionnaire on early life exposures and lifestyle in a case–control study

V. Rigalleau, A. Valleron, Jacques Cohen, 2016, bioRxiv.

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

Kimberley Jackson, Ivelina Gueorguieva, Jenny Y Chien, 2010, British journal of clinical pharmacology.

First-in-Human Dose Study of the Novel Transforming Growth Factor-β Receptor I Kinase Inhibitor LY2157299 Monohydrate in Patients with Advanced Cancer and Glioma

J. Baselga, J. Seoane, L. Paz-Ares, 2014, Clinical Cancer Research.

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

Gordon Graham, Leon Aarons, Kayode Ogungbenro, 2007, Journal of Pharmacokinetics and Pharmacodynamics.

Software for optimal design in population pharmacokinetics and pharmacodynamics : a comparison

Andrew C. Hooker, Sergei Leonov, Sylvie Retout, 2007 .