Joakim Nyberg

Reflection on clinical and methodological issues in rare disease clinical trials.

Verbeeck, Johan; Geroldinger, Martin; Nyberg, Joakim; Thiel, Konstantin E. et al.

Part of Orphanet Journal of Rare Diseases, 2025

• DOI for Reflection on clinical and methodological issues in rare disease clinical trials.
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Optimizing designs in clinical trials with an application in treatment of Epidermolysis bullosa simplex, a rare genetic skin disease

Nyberg, Joakim; Hooker, Andrew; Zimmermann, Georg; Verbeeck, Johan et al.

Part of Computational Statistics & Data Analysis, 2024

• DOI for Optimizing designs in clinical trials with an application in treatment of Epidermolysis bullosa simplex, a rare genetic skin disease
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Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors

Faraj, Alan; Nyberg, Joakim; Blouse, Grant E.; Knudsen, Tom et al.

Part of Clinical Pharmacology and Therapeutics, p. 498-505, 2024

• DOI for Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors
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Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials

Geroldinger, Martin; Verbeeck, Johan; Hooker, Andrew C.; Thiel, Konstantin E. et al.

Part of Orphanet Journal of Rare Diseases, 2023

• DOI for Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials
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Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data: Differences, Similarities and Challenges Illustrated with Rifampicin

Keutzer, Lina; You, Huifang; Farnoud, Ali; Nyberg, Joakim et al.

Part of Pharmaceutics, 2022

• DOI for Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data: Differences, Similarities and Challenges Illustrated with Rifampicin
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Reflection on clinical and methodological issues in rare disease clinical trials.

Verbeeck, Johan; Geroldinger, Martin; Nyberg, Joakim; Thiel, Konstantin E. et al.

Part of Orphanet Journal of Rare Diseases, 2025

• DOI for Reflection on clinical and methodological issues in rare disease clinical trials.
• Download full text (pdf) of Reflection on clinical and methodological issues in rare disease clinical trials.

Optimizing designs in clinical trials with an application in treatment of Epidermolysis bullosa simplex, a rare genetic skin disease

Nyberg, Joakim; Hooker, Andrew; Zimmermann, Georg; Verbeeck, Johan et al.

Part of Computational Statistics & Data Analysis, 2024

• DOI for Optimizing designs in clinical trials with an application in treatment of Epidermolysis bullosa simplex, a rare genetic skin disease
• Download full text (pdf) of Optimizing designs in clinical trials with an application in treatment of Epidermolysis bullosa simplex, a rare genetic skin disease

Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors

Faraj, Alan; Nyberg, Joakim; Blouse, Grant E.; Knudsen, Tom et al.

Part of Clinical Pharmacology and Therapeutics, p. 498-505, 2024

• DOI for Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors
• Download full text (pdf) of Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors

Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials

Geroldinger, Martin; Verbeeck, Johan; Hooker, Andrew C.; Thiel, Konstantin E. et al.

Part of Orphanet Journal of Rare Diseases, 2023

• DOI for Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials
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Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data: Differences, Similarities and Challenges Illustrated with Rifampicin

Keutzer, Lina; You, Huifang; Farnoud, Ali; Nyberg, Joakim et al.

Part of Pharmaceutics, 2022

• DOI for Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data: Differences, Similarities and Challenges Illustrated with Rifampicin
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An introduction of the full random effects model

Yngman, Gunnar; Nyberg, Henrik B.; Nyberg, Joakim; Jonsson, E. Niclas et al.

Part of CPT, p. 149-160, 2022

• DOI for An introduction of the full random effects model
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Population Kinetics of 0.9% Saline Distribution in Hemorrhaged Awake and Isoflurane-anesthetized Volunteers

Nyberg, Joakim; Li, Husong; Wessmark, Pehr; Winther, Viktor et al.

Part of Anesthesiology, p. 501-511, 2019

• DOI for Population Kinetics of 0.9% Saline Distribution in Hemorrhaged Awake and Isoflurane-anesthetized Volunteers

PKPDSimulator.jl: A simulation engine for drug development and clinical therapeutics in Julia

Rackauckas, Christopher; Nyberg, Joakim; Ivaturi, Vijay

Part of Journal of Pharmacokinetics and Pharmacodynamics, 2018

Implicit and efficient handling of missing covariate information using full random effects modelling

Nyberg, Joakim; Karlsson, Mats O; Jonsson, Niclas E.

Part of Journal of Pharmacokinetics and Pharmacodynamics, 2018

Second order Taylor expansion of likelihood-based models

Aoki, Yasunori; Nyberg, Joakim; Karlsson, Mats O.

Part of Journal of Pharmacokinetics and Pharmacodynamics, 2017

Analysis of opioid consumption in clinical trials: a simulation based analysis of power of four approaches

Juul, Rasmus Vestergaard; Nyberg, Joakim; Kreilgaard, Mads; Christrup, Lona Louring et al.

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 325-333, 2017

• DOI for Analysis of opioid consumption in clinical trials: a simulation based analysis of power of four approaches

Edoxaban Exposure-Response Analysis and Clinical Utility Index Assessment in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

Nyberg, Joakim; Karlsson, Kristin E.; Jönsson, Siv; Yin, O. Q. P. et al.

Part of CPT, p. 222-232, 2016

• DOI for Edoxaban Exposure-Response Analysis and Clinical Utility Index Assessment in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
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The effect of Fisher information matrix approximation methods in population optimal design calculations

Strömberg, Eric; Nyberg, Joakim; Hooker, Andrew

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 609-619, 2016

• DOI for The effect of Fisher information matrix approximation methods in population optimal design calculations
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A Pharmacokinetic-Pharmacodynamic Model of Morphine Exposure and Subsequent Morphine Consumption in Postoperative Pain

Juul, Rasmus Vestergaard; Nyberg, Joakim; Lund, Trine Meldgaard; Rasmussen, Sten et al.

Part of Pharmaceutical research, p. 1093-1103, 2016

• DOI for A Pharmacokinetic-Pharmacodynamic Model of Morphine Exposure and Subsequent Morphine Consumption in Postoperative Pain

Handling Underlying Discrete Variables with Mixed Hidden Markov Models in NONMEM

Plan, Elodie L.; Nyberg, Joakim; Bauer, Robert J.; Karlsson, Mats O.

Part of Journal of Pharmacokinetics and Pharmacodynamics, 2015

Population pharmacokinetics of edoxaban in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism-the Hokusai-VTE phase 3 study

Niebecker, Ronald; Jönsson, Siv; Karlsson, Mats O; Miller, Raymond et al.

Part of British Journal of Clinical Pharmacology, p. 1374-1387, 2015

• DOI for Population pharmacokinetics of edoxaban in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism-the Hokusai-VTE phase 3 study

Inter occasion variability in individual optimal design

Kristoffersson, Anders N.; Friberg, Lena E.; Nyberg, Joakim

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 735-750, 2015

• DOI for Inter occasion variability in individual optimal design
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Methods and software tools for design evaluation for population pharmacokinetics-pharmacodynamics studies

Nyberg, Joakim; Bazzoli, Caroline; Ogungbenro, Kay; Aliev, Alexander et al.

Part of British Journal of Clinical Pharmacology, p. 6-17, 2015

• DOI for Methods and software tools for design evaluation for population pharmacokinetics-pharmacodynamics studies

Optimal clinical trial design based on a dichotomous Markov-chain mixed-effect sleep model

Ernest II, Charles; Nyberg, Joakim; Karlsson, Mats O.; Hooker, Andrew C.

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 639-654, 2014

• DOI for Optimal clinical trial design based on a dichotomous Markov-chain mixed-effect sleep model
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Optimizing disease progression study designs for drug effect discrimination

Ueckert, Sebastian; Hennig, Stefanie; Nyberg, Joakim; Karlsson, Mats O. et al.

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 587-596, 2013

• DOI for Optimizing disease progression study designs for drug effect discrimination

Handling of Inter Occasion Variability (IOV) in Individual Optimal Design (OD) of a Colistin PK Sampling Schedule

Kristoffersson, Anders N.; Friberg, Lena E.; Nyberg, Joakim

Part of Journal of Pharmacokinetics and Pharmacodynamics, 2013

Rapid Sample Size Calculations for a Defined Likelihood Ratio Test-Based Power in Mixed-Effects Models

Vong, Camille; Bergstrand, Martin; Nyberg, Joakim; Karlsson, Mats O.

Part of AAPS Journal, p. 176-186, 2012

• DOI for Rapid Sample Size Calculations for a Defined Likelihood Ratio Test-Based Power in Mixed-Effects Models

PopED: An extended, parallelized, nonlinear mixed effects models optimal design tool

Nyberg, Joakim; Ueckert, Sebastian; Strömberg, Eric; Hennig, Stefanie et al.

Part of Computer Methods and Programs in Biomedicine, p. 789-805, 2012

• DOI for PopED: An extended, parallelized, nonlinear mixed effects models optimal design tool

Serial correlation in optimal design for nonlinear mixed effects models

Nyberg, Joakim; Höglund, Richard; Bergstrand, Martin; Karlsson, Mats O. et al.

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 239-249, 2012

• DOI for Serial correlation in optimal design for nonlinear mixed effects models

Application of the Optimal Design Approach to Improve a Pretransplant Drug Dose Finding Design for Ciclosporin

Hennig, Stefanie; Nyberg, Joakim; Fanta, Samuel; Backman, Janne T. et al.

Part of Journal of clinical pharmacology, p. 347-360, 2012

• DOI for Application of the Optimal Design Approach to Improve a Pretransplant Drug Dose Finding Design for Ciclosporin

Ethically Attractive Dose-Finding Designs for Drugs With a Narrow Therapeutic Index

Lledó-García, Rocío; Hennig, Stefanie; Nyberg, Joakim; Hooker, Andrew C et al.

Part of Journal of clinical pharmacology, p. 29-38, 2012

• DOI for Ethically Attractive Dose-Finding Designs for Drugs With a Narrow Therapeutic Index

Optimised protocol design for the screening of analgesic compounds in neuropathic pain.

Taneja, A; Nyberg, J; Danhof, M; Della Pasqua, O

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 661-671, 2012

• DOI for Optimised protocol design for the screening of analgesic compounds in neuropathic pain.

Application of ED-optimality to screening experiments for analgesic compounds in an experimental model of neuropathic pain.

Taneja, A; Nyberg, J; de Lange, E C M; Danhof, M et al.

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 673-681, 2012

• DOI for Application of ED-optimality to screening experiments for analgesic compounds in an experimental model of neuropathic pain.

Optimal Design in Population Kinetic Experiments by Set-Valued Methods

Gennemark, Peter; Danis, Alexander; Nyberg, Joakim; Hooker, Andrew C. et al.

Part of AAPS Journal, p. 495-507, 2011

• DOI for Optimal Design in Population Kinetic Experiments by Set-Valued Methods

Optimal experimental design for assessment of enzyme kinetics in a drug discovery screening environment

Sjögren, Erik; Nyberg, Joakim; Magnusson, Mats O.; Lennernäs, Hans et al.

Part of Drug Metabolism And Disposition, p. 858-863, 2011

• DOI for Optimal experimental design for assessment of enzyme kinetics in a drug discovery screening environment

Population Pharmacokinetic Modeling and Optimal Sampling Strategy for Bayesian Estimation of Amikacin Exposure in Critically Ill Septic Patients

Delattre, Isabelle K.; Musuamba, Flora T.; Nyberg, Joakim; Taccone, Fabio S. et al.

Part of Therapeutic Drug Monitoring, p. 749-756, 2010

• DOI for Population Pharmacokinetic Modeling and Optimal Sampling Strategy for Bayesian Estimation of Amikacin Exposure in Critically Ill Septic Patients

Adaptive-Optimal Design in PET Occupancy Studies

Zamuner, S.; Di Iorio, V. L.; Nyberg, Joakim; Gunn, R. N. et al.

Part of Clinical Pharmacology and Therapeutics, p. 563-571, 2010

• DOI for Adaptive-Optimal Design in PET Occupancy Studies

Trial treatment length optimization with an emphasis on disease progression studies

Hennig, Stefanie; Nyberg, Joakim; Hooker, Andrew C; Karlsson, Mats O

Part of Journal of clinical pharmacology, p. 323-335, 2009

• DOI for Trial treatment length optimization with an emphasis on disease progression studies

Simultaneous optimal experimental design on dose and sample times

Nyberg, Joakim; Karlsson, Mats O.; Hooker, Andrew C.

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 125-145, 2009

• DOI for Simultaneous optimal experimental design on dose and sample times

Optimization of the intravenous glucose tolerance test in T2DM patients using optimal experimental design

Silber, Hanna E.; Nyberg, Joakim; Hooker, Andrew C.; Karlsson, Mats O.

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 281-295, 2009

• DOI for Optimization of the intravenous glucose tolerance test in T2DM patients using optimal experimental design
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The Lasso – A Novel Method for Predictive Covariate Model Building in Nonlinear Mixed Effects Models

Ribbing, Jakob; Nyberg, Joakim; Caster, Ola; Jonsson, E. Niclas

Part of Journal of Pharmacokinetics and Pharmacodynamics, p. 485-517, 2007

• DOI for The Lasso – A Novel Method for Predictive Covariate Model Building in Nonlinear Mixed Effects Models

Practical Optimal Experimental Design in Drug Development and Drug Treatment using Nonlinear Mixed Effects Models

Nyberg, Joakim

2011

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Handling Below Limit of Quantification Data in Optimal Trial Design

Vong, Camille; Ueckert, Sebastian; Nyberg, Joakim; Hooker, Andrew C.

2014

Nutritional supplementation in patients after coronary-bypass surgery for unstable angina pectoris

Rapp-Kesek, Doris; Rosborg, Helena; Wilbrand, Kerstin; Nyberg, Joakim et al.

2012

Optimal Design Applied to Hematological Toxicity-Induced Anticancer Treatment

Vong, Camille; Nyberg, Joakim; Karlsson, Mats O.; Friberg, Lena E. et al.

Model-based approaches to prospectively power pediatric pharmacokinetic trials with limited sample size

Faraj, Alan; Ayoun Alsoud, Rami; Nyberg, Joakim; Simonsson, Ulrika S. H.