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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

Investigational new drugs, 2020-10, Vol.38 (5), p.1570-1579

2020

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

Liver international, 2019-08, Vol.39 (8), p.1468-1477

2019

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

Drug design, development and therapy, 2015-01, Vol.9 (default), p.4479-4499

2015

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

BMC cancer, 2023-07, Vol.23 (1), p.708-708, Article 708

2023

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

Cancer medicine (Malden, MA), 2021-05, Vol.10 (9), p.3059-3067

2021

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

Alzheimer's & dementia : translational research & clinical interventions, 2023-04, Vol.9 (2), p.e12404-n/a

2023

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Optimal design for multiresponse pharmacokinetic-pharmacodynamic models - dealing with unbalanced designs

Journal of pharmacokinetics and pharmacodynamics, 2007-06, Vol.34 (3), p.313-331

2007

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

Clinical pharmacology and therapeutics, 2023-06, Vol.113 (6), p.1258-1267

2023

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

Neuro-oncology (Charlottesville, Va.), 2016-08, Vol.18 (8), p.1146-1156

2016

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

Alzheimer's & dementia, 2023-06, Vol.19 (S7), p.n/a

2023

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

Clinical cancer research, 2019-12, Vol.25 (23), p.6976-6985

2019

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

European journal of cancer (1990), 2016-10, Vol.66, p.95-103

2016

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

Alzheimer's & dementia, 2023-06, Vol.19 (6), p.2253-2264

2023

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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

European journal of pharmaceutical sciences, 2021-06, Vol.161, p.105781-105781, Article 105781

2021

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

Alzheimer's & dementia, 2023-12, Vol.19 (S14), p.n/a

2023

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

Pharmaceutical research, 2014-10, Vol.31 (10), p.2829-2843

2014

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

British journal of clinical pharmacology, 2016-09, Vol.82 (3), p.717-727

2016

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ACTR-16. PHASE 2 STUDY EVALUATING SAFETY, PHARMACOKINETICS (PK), PHARMACODYNAMICS (PD) AND EFFICACY OF THE ORAL TRANSFORMING GROWTH FACTOR-BETA (TGF-β) RECEPTOR I KINASE INHIBITOR GALUNISERTIB WHEN COMBINED WITH CHEMORADIOTHERAPY IN NEWLY DIAGNOSED MALIGNANT GLIOMA

Neuro-oncology (Charlottesville, Va.), 2016-11, Vol.18 (suppl_6), p.vi4-vi4

2016

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Fuzzy simulation of pharmacokinetic models: Case study of whole body physiologically based model of diazepam

Journal of pharmacokinetics and pharmacodynamics, 2004-06, Vol.31 (3), p.185-213

2004

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Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2)

Journal of thoracic oncology, 2021-02, Vol.16 (2), p.327-333

2021

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Mechanism for Enhanced Absorption of a Solid Dispersion Formulation of LY2300559 Using the Artificial Stomach Duodenum Model

Molecular pharmaceutics, 2015-04, Vol.12 (4), p.1131-1140

2015

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

Drug metabolism and disposition, 2002-03, Vol.30 (3), p.276

2002

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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

Journal of clinical oncology, 2019-05, Vol.37 (15_suppl), p.4124-4124

2019

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A phase 2 study of galunisertib (TGF-Β R1 inhibitor) and sorafenib in patients with advanced hepatocellular carcinoma (HCC)

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.4097-4097

2017

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

Journal of pharmacokinetics and pharmacodynamics, 2012-04, Vol.39 (2), p.147-160

2012

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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

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

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

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

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

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

Optimal design for multiresponse pharmacokinetic-pharmacodynamic models - dealing with unbalanced designs

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

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

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

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

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

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

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

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

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

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

ACTR-16. PHASE 2 STUDY EVALUATING SAFETY, PHARMACOKINETICS (PK), PHARMACODYNAMICS (PD) AND EFFICACY OF THE ORAL TRANSFORMING GROWTH FACTOR-BETA (TGF-β) RECEPTOR I KINASE INHIBITOR GALUNISERTIB WHEN COMBINED WITH CHEMORADIOTHERAPY IN NEWLY DIAGNOSED MALIGNANT GLIOMA

Fuzzy simulation of pharmacokinetic models: Case study of whole body physiologically based model of diazepam

Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2)

Mechanism for Enhanced Absorption of a Solid Dispersion Formulation of LY2300559 Using the Artificial Stomach Duodenum Model

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

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

A phase 2 study of galunisertib (TGF-Β R1 inhibitor) and sorafenib in patients with advanced hepatocellular carcinoma (HCC)

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

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