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Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology

British journal of clinical pharmacology, 2021-06, Vol.87 (6), p.2493-2501

2021

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A New Method to Model and Predict Progression Free Survival Based on Tumor Growth Dynamics

CPT: pharmacometrics and systems pharmacology, 2020-03, Vol.9 (3), p.177-184

2020

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A longitudinal model for the Mayo Clinical Score and its sub-components in patients with ulcerative colitis

Journal of pharmacokinetics and pharmacodynamics, 2022-04, Vol.49 (2), p.179-190

2022

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Intrinsic and Extrinsic Pharmacokinetic Variability of Small Molecule Targeted Cancer Therapy

Clinical and translational science, 2020-03, Vol.13 (2), p.410-418

2020

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Analysis of Longitudinal‐Ordered Categorical Data for Muscle Spasm Adverse Event of Vismodegib: Comparison Between Different Pharmacometric Models

CPT: pharmacometrics and systems pharmacology, 2020-02, Vol.9 (2), p.96-105

2020

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A positron emission tomography study in healthy volunteers to estimate mGluR5 receptor occupancy of AZD2066 — Estimating occupancy in the absence of a reference region

NeuroImage (Orlando, Fla.), 2013-11, Vol.82, p.160-169

2013

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Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates?

Clinical pharmacology and therapeutics, 2021-11, Vol.110 (5), p.1216-1230

2021

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Estimation of drug receptor occupancy when non‐displaceable binding differs between brain regions – extending the simplified reference tissue model

British journal of clinical pharmacology, 2015-07, Vol.80 (1), p.116-127

2015

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Support to early clinical decisions in drug development and personalised medicine with checkpoint inhibitors using dynamic biomarker-overall survival models

British journal of cancer, 2023-10, Vol.129 (9), p.1383-1388

2023

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Improved precision of exposure–response relationships by optimal dose-selection. Examples from studies of receptor occupancy using PET and dose finding for neuropathic pain treatment

Journal of pharmacokinetics and pharmacodynamics, 2015-06, Vol.42 (3), p.211-224

2015

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Simulation‐based evaluation of personalized dosing approaches for anti‐FGFR/KLB bispecific antibody fazpilodemab

CPT: pharmacometrics and systems pharmacology, 2024-04, Vol.13 (4), p.544-550

2024

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Population pharmacokinetic and exploratory exposure–response analysis of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer in the FeDeriCa study

Cancer chemotherapy and pharmacology, 2021-09, Vol.88 (3), p.499-512

2021

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Population Pharmacokinetics of Ranibizumab Delivered via the Port Delivery System Implanted in the Eye in Patients with Neovascular Age-Related Macular Degeneration

Journal of clinical pharmacology, 2023-11, Vol.63 (11), p.1210-1220

2023

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Development of a Subcutaneous Fixed‐Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose‐Finding Study

Journal of clinical pharmacology, 2019-05, Vol.59 (5), p.702-716

2019

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Early phase drug development for treatment of chronic pain — Options for clinical trial and program design

Contemporary clinical trials, 2012-07, Vol.33 (4), p.689-699

2012

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A disease model predicting placebo response and remission status of patients with ulcerative colitis using modified Mayo score

Clinical and translational science, 2023-11, Vol.16 (11), p.2310-2322

2023

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gPKPDviz: A flexible R shiny tool for pharmacokinetic/pharmacodynamic simulations using mrgsolve

CPT: pharmacometrics and systems pharmacology, 2024-03, Vol.13 (3), p.341-358

2024

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Assessment of pharmacokinetic linearity after repeated drug administration

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-09, Vol.21 (5), p.932-943

2022

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Norepinephrine transporter occupancy in the human brain after oral administration of quetiapine XR

The international journal of neuropsychopharmacology, 2013-11, Vol.16 (10), p.2235-2244

2013

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Pharmacokinetics of the Port Delivery System with Ranibizumab in the Ladder Phase 2 Trial for Neovascular Age-Related Macular Degeneration

Ophthalmology and therapy, 2022-10, Vol.11 (5), p.1705-1717

2022

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Non-linear mixed effects modelling of positron emission tomography data for simultaneous estimation of radioligand kinetics and occupancy in healthy volunteers

NeuroImage (Orlando, Fla.), 2012-07, Vol.61 (4), p.849-856

2012

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Pharmacokinetic-pharmacodynamic modeling of fostamatinib efficacy on ACR20 to support dose selection in patients with rheumatoid arthritis (RA)

Journal of clinical pharmacology, 2015-03, Vol.55 (3), p.328-335

2015

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Modelling a spontaneously reported side effect by use of a markov mixed-effects model

Journal of pharmacokinetics and pharmacodynamics, 2005-04, Vol.32 (2), p.261-281

2005

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Time‐to‐Event Modeling of Peripheral Neuropathy: Platform Analysis of Eight Valine‐Citrulline‐Monomethylauristatin E Antibody–Drug Conjugates

CPT: pharmacometrics and systems pharmacology, 2019-08, Vol.8 (8), p.606-615

2019

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Pharmacokinetic and exploratory exposure–response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study

Cancer chemotherapy and pharmacology, 2019-06, Vol.83 (6), p.1147-1158

2019

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Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology

A New Method to Model and Predict Progression Free Survival Based on Tumor Growth Dynamics

A longitudinal model for the Mayo Clinical Score and its sub-components in patients with ulcerative colitis

Intrinsic and Extrinsic Pharmacokinetic Variability of Small Molecule Targeted Cancer Therapy

Analysis of Longitudinal‐Ordered Categorical Data for Muscle Spasm Adverse Event of Vismodegib: Comparison Between Different Pharmacometric Models

A positron emission tomography study in healthy volunteers to estimate mGluR5 receptor occupancy of AZD2066 — Estimating occupancy in the absence of a reference region

Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates?

Estimation of drug receptor occupancy when non‐displaceable binding differs between brain regions – extending the simplified reference tissue model

Support to early clinical decisions in drug development and personalised medicine with checkpoint inhibitors using dynamic biomarker-overall survival models

Improved precision of exposure–response relationships by optimal dose-selection. Examples from studies of receptor occupancy using PET and dose finding for neuropathic pain treatment

Simulation‐based evaluation of personalized dosing approaches for anti‐FGFR/KLB bispecific antibody fazpilodemab

Population pharmacokinetic and exploratory exposure–response analysis of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer in the FeDeriCa study

Population Pharmacokinetics of Ranibizumab Delivered via the Port Delivery System Implanted in the Eye in Patients with Neovascular Age-Related Macular Degeneration

Development of a Subcutaneous Fixed‐Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose‐Finding Study

Early phase drug development for treatment of chronic pain — Options for clinical trial and program design

A disease model predicting placebo response and remission status of patients with ulcerative colitis using modified Mayo score

gPKPDviz: A flexible R shiny tool for pharmacokinetic/pharmacodynamic simulations using mrgsolve

Assessment of pharmacokinetic linearity after repeated drug administration

Norepinephrine transporter occupancy in the human brain after oral administration of quetiapine XR

Pharmacokinetics of the Port Delivery System with Ranibizumab in the Ladder Phase 2 Trial for Neovascular Age-Related Macular Degeneration

Non-linear mixed effects modelling of positron emission tomography data for simultaneous estimation of radioligand kinetics and occupancy in healthy volunteers

Pharmacokinetic-pharmacodynamic modeling of fostamatinib efficacy on ACR20 to support dose selection in patients with rheumatoid arthritis (RA)

Modelling a spontaneously reported side effect by use of a markov mixed-effects model

Time‐to‐Event Modeling of Peripheral Neuropathy: Platform Analysis of Eight Valine‐Citrulline‐Monomethylauristatin E Antibody–Drug Conjugates

Pharmacokinetic and exploratory exposure–response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study

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