Andrew Hooker

The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

Fang, Lanyan; Gong, Yuqing; Hooker, Andrew; Lukacova, Viera et al.

Ingår i AAPS Journal, 2024

• DOI för The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

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.

Ingår i Orphanet Journal of Rare Diseases, 2023

• DOI för Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials
• Ladda ner fulltext (pdf) av Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials

Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop

Gong, Yuqing; Zhang, Peijue; Yoon, Miyoung; Zhu, Hao et al.

Ingår i CPT, s. 624-630, 2023

• DOI för Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop
• Ladda ner fulltext (pdf) av Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop

Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Lyauk, Yassine Kamal; Jonker, Daniel M.; Hooker, Andrew; Lund, Trine Meldgaard et al.

Ingår i AAPS Journal, 2021

• DOI för Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
• Ladda ner fulltext (pdf) av Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Pharmacometrics meets statistics-A synergy for modern drug development

Ryeznik, Yevgen; Sverdlov, Oleksandr; Svensson, Elin; Montepiedra, Grace et al.

Ingår i CPT, s. 1134-1149, 2021

• DOI för Pharmacometrics meets statistics-A synergy for modern drug development
• Ladda ner fulltext (pdf) av Pharmacometrics meets statistics-A synergy for modern drug development

Metaheuristics for pharmacometrics

Kim, Seongho; Hooker, Andrew; Shi, Yu; Kim, Grace Hyun J. et al.

Ingår i CPT, s. 1297-1309, 2021

• DOI för Metaheuristics for pharmacometrics
• Ladda ner fulltext (pdf) av Metaheuristics for pharmacometrics

Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization

Bauer, Robert J.; Hooker, Andrew; Mentre, France

Ingår i CPT, s. 1452-1465, 2021

• DOI för Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization
• Ladda ner fulltext (pdf) av Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.

Lee, Jieon; Gong, Yuqing; Bhoopathy, Sid; DiLiberti, Charles E et al.

Ingår i Clinical Pharmacology and Therapeutics, s. 1190-1195, 2021

• DOI för Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.
• Ladda ner fulltext (pdf) av Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.

Model-Informed Drug Development for Long-Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium

Sharan, Satish; Fang, Lanyan; Lukacova, Viera; Chen, Xiaomei et al.

Ingår i Clinical Pharmacology in Drug Development, s. 220-228, 2021

• DOI för Model-Informed Drug Development for Long-Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium

Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia

Lyauk, Yassine Kamal; Jonker, Daniel M.; Lund, Trine Meldgaard; Hooker, Andrew et al.

Ingår i AAPS Journal, 2020

• DOI för Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia
• Ladda ner fulltext (pdf) av Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia

Population Pharmacokinetics and Dosing of Ethionamide in Children with Tuberculosis

Bjugård Nyberg, Henrik; Draper, Heather R.; Garcia-Prats, Anthony J.; Thee, Stephanie et al.

Ingår i Antimicrobial Agents and Chemotherapy, 2020

• DOI för Population Pharmacokinetics and Dosing of Ethionamide in Children with Tuberculosis

Saddle-Reset for Robust Parameter Estimation and Identifiability Analysis of Nonlinear Mixed Effects Models

Bjugård Nyberg, Henrik; Hooker, Andrew C.; Bauer, Robert J; Aoki, Yasunori

Ingår i AAPS Journal, 2020

• DOI för Saddle-Reset for Robust Parameter Estimation and Identifiability Analysis of Nonlinear Mixed Effects Models
• Ladda ner fulltext (pdf) av Saddle-Reset for Robust Parameter Estimation and Identifiability Analysis of Nonlinear Mixed Effects Models

Optimizing Dose-Finding Studies for Drug Combinations Based on Exposure-Response Models

Papathanasiou, Theodoros; Strathe, Anders; Overgaard, Rune Viig; Lund, Trine Meldgaard et al.

Ingår i AAPS Journal, 2019

• DOI för Optimizing Dose-Finding Studies for Drug Combinations Based on Exposure-Response Models

Feasibility of Exposure-Response Analyses for Clinical Dose-Ranging Studies of Drug Combinations

Papathanasiou, Theodoros; Strathe, Anders; Hooker, Andrew C.; Lund, Trine Meldgaard et al.

Ingår i AAPS Journal, 2018

• DOI för Feasibility of Exposure-Response Analyses for Clinical Dose-Ranging Studies of Drug Combinations

Adaptive Optimal Designs for Dose-Finding Studies with Time-to-Event Outcomes

Ryeznik, Yevgen; Sverdlov, Oleksandr; Hooker, Andrew C

Ingår i AAPS Journal, 2018

• DOI för Adaptive Optimal Designs for Dose-Finding Studies with Time-to-Event Outcomes
• Ladda ner fulltext (pdf) av Adaptive Optimal Designs for Dose-Finding Studies with Time-to-Event Outcomes

A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim

Brekkan, Ari; Lopez-Lazaro, Luis; Yngman, Gunnar; Plan, Elodie L. et al.

Ingår i AAPS Journal, 2018

• DOI för A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim
• Ladda ner fulltext (pdf) av A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim

Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group

Ryeznik, Yevgen; Sverdlov, Oleksandr; Hooker, Andrew

Ingår i AAPS Journal, 2018

• DOI för Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group
• Ladda ner fulltext (pdf) av Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group

Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology

Pierrillas, Philippe B.; Fouliard, Sylvain; Chenel, Marylore; Hooker, Andrew et al.

Ingår i AAPS Journal, 2018

• DOI för Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology
• Ladda ner fulltext (pdf) av Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology

Reduced and optimized trial designs for drugs described by a target mediated drug disposition model

Brekkan, Ari; Jönsson, Siv; Karlsson, Mats O; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 637-647, 2018

• DOI för Reduced and optimized trial designs for drugs described by a target mediated drug disposition model
• Ladda ner fulltext (pdf) av Reduced and optimized trial designs for drugs described by a target mediated drug disposition model

Model-Informed Drug Development and Review for Generic Products: Summary Of FDA Public Workshop

Fang, Lanyan; Kim, Myong-Jin; Li, Zhichuan; Wang, Yaning et al.

Ingår i Clinical Pharmacology and Therapeutics, s. 27-30, 2018

• DOI för Model-Informed Drug Development and Review for Generic Products: Summary Of FDA Public Workshop

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)

Musuamba, F. T.; Manolis, E.; Holford, N.; Cheung, S. Y. A. et al.

Ingår i CPT, s. 418-429, 2017

• DOI för Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)

Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics

Nguyen, T. H. T.; Mouksassi, M-S; Holford, N.; Al-Huniti, N. et al.

Ingår i CPT, s. 87-109, 2017

• DOI för Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics
• Ladda ner fulltext (pdf) av Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics

Assessing robustness of designs for random effects parameters for nonlinear mixed-effects models

Duffull, Stephen B.; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 611-616, 2017

• DOI för Assessing robustness of designs for random effects parameters for nonlinear mixed-effects models

Model selection and averaging of nonlinear mixed-effect models for robust phase III dose selection

Aoki, Yasunori; Roshammar, Daniel; Hamren, Bengt; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 581-597, 2017

• DOI för Model selection and averaging of nonlinear mixed-effect models for robust phase III dose selection
• Ladda ner fulltext (pdf) av Model selection and averaging of nonlinear mixed-effect models for robust phase III dose selection

The effect of using a robust optimality criterion in model based adaptive optimization.

Strömberg, Eric; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 317-324, 2017

• DOI för The effect of using a robust optimality criterion in model based adaptive optimization.
• Ladda ner fulltext (pdf) av The effect of using a robust optimality criterion in model based adaptive optimization.

Preconditioning of Nonlinear Mixed Effects Models for Stabilisation of Variance-Covariance Matrix Computations

Aoki, Yasunori; Nordgren, Rikard; Hooker, Andrew C.

Ingår i AAPS Journal, s. 505-518, 2016

• DOI för Preconditioning of Nonlinear Mixed Effects Models for Stabilisation of Variance-Covariance Matrix Computations

Accelerating Monte Carlo power studies through parametric power estimation

Ueckert, Sebastian; Karlsson, Mats O.; Hooker, Andrew C

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 223-234, 2016

• DOI för Accelerating Monte Carlo power studies through parametric power estimation
• Ladda ner fulltext (pdf) av Accelerating Monte Carlo power studies through parametric power estimation

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

Kågedal, Matts; Karlsson, Mats; Hooker, Andrew C

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 211-224, 2015

• DOI för 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

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

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

Ingår i British Journal of Clinical Pharmacology, s. 6-17, 2015

• DOI för 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.

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 639-654, 2014

• DOI för Optimal clinical trial design based on a dichotomous Markov-chain mixed-effect sleep model
• Ladda ner fulltext (pdf) av Optimal clinical trial design based on a dichotomous Markov-chain mixed-effect sleep model

Improved Utilization of ADAS-cog Assessment Data through Item Response Theory based Pharmacometric Modeling

Ueckert, Sebastian; Plan, Elodie L.; Ito, Kaori; Karlsson, Mats O. et al.

Ingår i Pharmaceutical research, s. 2152-2165, 2014

• DOI för Improved Utilization of ADAS-cog Assessment Data through Item Response Theory based Pharmacometric Modeling
• Ladda ner fulltext (pdf) av Improved Utilization of ADAS-cog Assessment Data through Item Response Theory based Pharmacometric Modeling

Modeling and Simulation Workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose

Keizer, Ron J; Karlsson, M O; Hooker, Andrew C

Ingår i CPT, 2013

• DOI för Modeling and Simulation Workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose

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

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

Ingår i Computer Methods and Programs in Biomedicine, s. 789-805, 2012

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

Prediction-Corrected Visual Predictive Checks for Diagnosing Nonlinear Mixed-Effects Models

Bergstrand, Martin; Hooker, Andrew C.; Wallin, Johan E.; Karlsson, Mats O.

Ingår i AAPS Journal, s. 143-151, 2011

• DOI för Prediction-Corrected Visual Predictive Checks for Diagnosing Nonlinear Mixed-Effects Models

Optimal Design in Population Kinetic Experiments by Set-Valued Methods

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

Ingår i AAPS Journal, s. 495-507, 2011

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

Adaptive-Optimal Design in PET Occupancy Studies

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

Ingår i Clinical Pharmacology and Therapeutics, s. 563-571, 2010

• DOI för Adaptive-Optimal Design in PET Occupancy Studies

Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method

Hooker, Andrew C.; Staatz, Christine E; Karlsson, Mats O

Ingår i Pharmaceutical research, s. 2187-2197, 2007

• DOI för Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method

Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments.

Hooker, Andrew C.; Vicini, Paolo

Ingår i AAPS Journal, 2005

• DOI för Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments.

Robust population pharmacokinetic experiment design.

Dodds, Michael G; Hooker, Andrew C.; Vicini, Paolo

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 33-64, 2005

• DOI för Robust population pharmacokinetic experiment design.

Optimizing Clinical Study Designs for CAR-T Cell Therapy: Development of an Efficient Sampling Strategy Through Optimal Experimental Design

Klima, Fenja; Mc Laughlin, Anna M.; Michelet, Robin; Huisinga, Wilhelm et al.

Ingår i CPT, 2026

• DOI för Optimizing Clinical Study Designs for CAR-T Cell Therapy: Development of an Efficient Sampling Strategy Through Optimal Experimental Design
• Ladda ner fulltext (pdf) av Optimizing Clinical Study Designs for CAR-T Cell Therapy: Development of an Efficient Sampling Strategy Through Optimal Experimental Design

In Silico Clinical Trials in Drug Development: A Systematic Review

Chen, Bohua; Schneider, Lucia Chantal; Röver, Christian; Comets, Emmanuelle et al.

Ingår i Therapeutic Innovation and Regulatory Science, s. 423-439, 2026

• DOI för In Silico Clinical Trials in Drug Development: A Systematic Review
• Ladda ner fulltext (pdf) av In Silico Clinical Trials in Drug Development: A Systematic Review

Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases

Hamdan, Alzahra; Traschütz, Andreas; Beichert, Lukas; Chen, Xiaomei et al.

Ingår i CPT, s. 1857-1868, 2025

• DOI för Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases
• Ladda ner fulltext (pdf) av Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases

A Pharmacometrics-Informed Trial Simulation Framework for Optimizing Study Designs for Disease-Modifying Treatments in Rare Neurological Disorders

Ryeznik, Yevgen; Hilgers, Ralf-Dieter; Heussen, Nicole; Comets, Emmanuelle et al.

Ingår i CPT, s. 1705-1714, 2025

• DOI för A Pharmacometrics-Informed Trial Simulation Framework for Optimizing Study Designs for Disease-Modifying Treatments in Rare Neurological Disorders
• Ladda ner fulltext (pdf) av A Pharmacometrics-Informed Trial Simulation Framework for Optimizing Study Designs for Disease-Modifying Treatments in Rare Neurological Disorders

Leveraging Model Master Files for Long-Acting Injectables

Gong, Yuqing; Hopefl, Robert; Li, Tonglei; Hooker, Andrew et al.

Ingår i Pharmaceutical research, s. 747-752, 2025

• DOI för Leveraging Model Master Files for Long-Acting Injectables
• Ladda ner fulltext (pdf) av Leveraging Model Master Files for Long-Acting Injectables

Optimizing Clinical Study Designs for CAR-T Cell Therapy: Development of an Efficient Sampling Strategy Through Optimal Experimental Design

Klima, Fenja; Mc Laughlin, Anna M.; Michelet, Robin; Huisinga, Wilhelm et al.

Ingår i CPT, 2026

• DOI för Optimizing Clinical Study Designs for CAR-T Cell Therapy: Development of an Efficient Sampling Strategy Through Optimal Experimental Design
• Ladda ner fulltext (pdf) av Optimizing Clinical Study Designs for CAR-T Cell Therapy: Development of an Efficient Sampling Strategy Through Optimal Experimental Design

Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases

Hamdan, Alzahra; Traschütz, Andreas; Beichert, Lukas; Chen, Xiaomei et al.

Ingår i CPT, s. 1857-1868, 2025

• DOI för Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases
• Ladda ner fulltext (pdf) av Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases

A Pharmacometrics-Informed Trial Simulation Framework for Optimizing Study Designs for Disease-Modifying Treatments in Rare Neurological Disorders

Ryeznik, Yevgen; Hilgers, Ralf-Dieter; Heussen, Nicole; Comets, Emmanuelle et al.

Ingår i CPT, s. 1705-1714, 2025

• DOI för A Pharmacometrics-Informed Trial Simulation Framework for Optimizing Study Designs for Disease-Modifying Treatments in Rare Neurological Disorders
• Ladda ner fulltext (pdf) av A Pharmacometrics-Informed Trial Simulation Framework for Optimizing Study Designs for Disease-Modifying Treatments in Rare Neurological Disorders

Leveraging Model Master Files for Long-Acting Injectables

Gong, Yuqing; Hopefl, Robert; Li, Tonglei; Hooker, Andrew et al.

Ingår i Pharmaceutical research, s. 747-752, 2025

• DOI för Leveraging Model Master Files for Long-Acting Injectables
• Ladda ner fulltext (pdf) av Leveraging Model Master Files for Long-Acting Injectables

Comparing randomized trial designs to estimate treatment effect in rare diseases with longitudinal models: a simulation study showcased by Autosomal Recessive Cerebellar Ataxias using the SARA score

Hendrickx, Niels; Mentré, France; Hamdan, Alzahra; Karlsson, Mats O. et al.

Ingår i BMC Medical Research Methodology, 2025

• DOI för Comparing randomized trial designs to estimate treatment effect in rare diseases with longitudinal models: a simulation study showcased by Autosomal Recessive Cerebellar Ataxias using the SARA score
• Ladda ner fulltext (pdf) av Comparing randomized trial designs to estimate treatment effect in rare diseases with longitudinal models: a simulation study showcased by Autosomal Recessive Cerebellar Ataxias using the SARA score

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

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

Ingår i Orphanet Journal of Rare Diseases, 2025

• DOI för Reflection on clinical and methodological issues in rare disease clinical trials.
• Ladda ner fulltext (pdf) av Reflection on clinical and methodological issues in rare disease clinical trials.

A Comparison of Statistical Methods for Time-To-Event Analyses in Randomized Controlled Trials Under Non-Proportional Hazards

Klinglmüller, Florian; Fellinger, Tobias; König, Franz; Friede, Tim et al.

Ingår i Statistics in Medicine, 2025

• DOI för A Comparison of Statistical Methods for Time-To-Event Analyses in Randomized Controlled Trials Under Non-Proportional Hazards
• Ladda ner fulltext (pdf) av A Comparison of Statistical Methods for Time-To-Event Analyses in Randomized Controlled Trials Under Non-Proportional Hazards

Optimizing the design of a pharmacokinetic trial to evaluate the dosing scheme of a novel tuberculosis drug in children living with or without HIV

Montepiedra, Grace; Svensson, Elin; Wong, Weng Kee; Hooker, Andrew

Ingår i CPT, s. 270-280, 2024

• DOI för Optimizing the design of a pharmacokinetic trial to evaluate the dosing scheme of a novel tuberculosis drug in children living with or without HIV
• Ladda ner fulltext (pdf) av Optimizing the design of a pharmacokinetic trial to evaluate the dosing scheme of a novel tuberculosis drug in children living with or without HIV

Evaluation of model-integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods

Bjugård Nyberg, Henrik; Chen, Xiaomei; Donnelly, Mark; Fang, Lanyan et al.

Ingår i CPT, s. 1748-1761, 2024

• DOI för Evaluation of model-integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods
• Ladda ner fulltext (pdf) av Evaluation of model-integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods

A fully automatic tool for development of population pharmacokinetic models

Chen, Xiaomei; Nordgren, Rikard; Belin, Stella; Hamdan, Alzahra et al.

Ingår i CPT, s. 1784-1797, 2024

• DOI för A fully automatic tool for development of population pharmacokinetic models
• Ladda ner fulltext (pdf) av A fully automatic tool for development of population pharmacokinetic models

Longitudinal Analysis of Natural History Progression of Rare and Ultra‐Rare Cerebellar Ataxias Using Item Response Theory

Hamdan, Alzahra; Hendrickx, Niels; Hooker, Andrew C.; Chen, Xiaomei et al.

Ingår i Clinical Pharmacology and Therapeutics, s. 1593-1605, 2024

• DOI för Longitudinal Analysis of Natural History Progression of Rare and Ultra‐Rare Cerebellar Ataxias Using Item Response Theory
• Ladda ner fulltext (pdf) av Longitudinal Analysis of Natural History Progression of Rare and Ultra‐Rare Cerebellar Ataxias Using Item Response Theory

Development and comparison of model-integrated evidence approaches for bioequivalence studies with pharmacokinetic end points

Chen, Xiaomei; Bjugård Nyberg, Henrik; Donnelly, Mark; Zhao, Liang et al.

Ingår i CPT, s. 1734-1747, 2024

• DOI för Development and comparison of model-integrated evidence approaches for bioequivalence studies with pharmacokinetic end points
• Ladda ner fulltext (pdf) av Development and comparison of model-integrated evidence approaches for bioequivalence studies with pharmacokinetic end points

Item performance of the scale for the assessment and rating of ataxia in rare and ultra-rare genetic ataxias

Hamdan, Alzahra; Hooker, Andrew C.; Chen, Xiaomei; Traschütz, Andreas et al.

Ingår i CPT, s. 1327-1340, 2024

• DOI för Item performance of the scale for the assessment and rating of ataxia in rare and ultra-rare genetic ataxias
• Ladda ner fulltext (pdf) av Item performance of the scale for the assessment and rating of ataxia in rare and ultra-rare genetic ataxias

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.

Ingår i Computational Statistics & Data Analysis, 2024

• DOI för Optimizing designs in clinical trials with an application in treatment of Epidermolysis bullosa simplex, a rare genetic skin disease
• Ladda ner fulltext (pdf) av Optimizing designs in clinical trials with an application in treatment of Epidermolysis bullosa simplex, a rare genetic skin disease

The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

Fang, Lanyan; Gong, Yuqing; Hooker, Andrew; Lukacova, Viera et al.

Ingår i AAPS Journal, 2024

• DOI för The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

Generation and application of avatars in pharmacometric modelling

Chasseloup, Estelle; Hooker, Andrew; Karlsson, Mats

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 411-423, 2023

• DOI för Generation and application of avatars in pharmacometric modelling
• Ladda ner fulltext (pdf) av Generation and application of avatars in pharmacometric modelling

How to Analyze Continuous and Discrete Repeated Measures in Small-Sample Cross-Over Trials?

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

Ingår i Biometrics, s. 3998-4011, 2023

• DOI för How to Analyze Continuous and Discrete Repeated Measures in Small-Sample Cross-Over Trials?

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.

Ingår i Orphanet Journal of Rare Diseases, 2023

• DOI för Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials
• Ladda ner fulltext (pdf) av Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials

Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Lyauk, Yassine Kamal; Jonker, Daniel M.; Hooker, Andrew; Lund, Trine Meldgaard et al.

Ingår i AAPS Journal, 2021

• DOI för Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
• Ladda ner fulltext (pdf) av Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Pharmacometrics meets statistics-A synergy for modern drug development

Ryeznik, Yevgen; Sverdlov, Oleksandr; Svensson, Elin; Montepiedra, Grace et al.

Ingår i CPT, s. 1134-1149, 2021

• DOI för Pharmacometrics meets statistics-A synergy for modern drug development
• Ladda ner fulltext (pdf) av Pharmacometrics meets statistics-A synergy for modern drug development

Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization

Bauer, Robert J.; Hooker, Andrew; Mentre, France

Ingår i CPT, s. 1452-1465, 2021

• DOI för Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization
• Ladda ner fulltext (pdf) av Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.

Lee, Jieon; Gong, Yuqing; Bhoopathy, Sid; DiLiberti, Charles E et al.

Ingår i Clinical Pharmacology and Therapeutics, s. 1190-1195, 2021

• DOI för Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.
• Ladda ner fulltext (pdf) av Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.

Model-Informed Drug Development for Long-Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium

Sharan, Satish; Fang, Lanyan; Lukacova, Viera; Chen, Xiaomei et al.

Ingår i Clinical Pharmacology in Drug Development, s. 220-228, 2021

• DOI för Model-Informed Drug Development for Long-Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium

Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia

Lyauk, Yassine Kamal; Jonker, Daniel M.; Lund, Trine Meldgaard; Hooker, Andrew et al.

Ingår i AAPS Journal, 2020

• DOI för Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia
• Ladda ner fulltext (pdf) av Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia

Population Pharmacokinetics and Dosing of Ethionamide in Children with Tuberculosis

Bjugård Nyberg, Henrik; Draper, Heather R.; Garcia-Prats, Anthony J.; Thee, Stephanie et al.

Ingår i Antimicrobial Agents and Chemotherapy, 2020

• DOI för Population Pharmacokinetics and Dosing of Ethionamide in Children with Tuberculosis

Saddle-Reset for Robust Parameter Estimation and Identifiability Analysis of Nonlinear Mixed Effects Models

Bjugård Nyberg, Henrik; Hooker, Andrew C.; Bauer, Robert J; Aoki, Yasunori

Ingår i AAPS Journal, 2020

• DOI för Saddle-Reset for Robust Parameter Estimation and Identifiability Analysis of Nonlinear Mixed Effects Models
• Ladda ner fulltext (pdf) av Saddle-Reset for Robust Parameter Estimation and Identifiability Analysis of Nonlinear Mixed Effects Models

Optimizing Dose-Finding Studies for Drug Combinations Based on Exposure-Response Models

Papathanasiou, Theodoros; Strathe, Anders; Overgaard, Rune Viig; Lund, Trine Meldgaard et al.

Ingår i AAPS Journal, 2019

• DOI för Optimizing Dose-Finding Studies for Drug Combinations Based on Exposure-Response Models

Feasibility of Exposure-Response Analyses for Clinical Dose-Ranging Studies of Drug Combinations

Papathanasiou, Theodoros; Strathe, Anders; Hooker, Andrew C.; Lund, Trine Meldgaard et al.

Ingår i AAPS Journal, 2018

• DOI för Feasibility of Exposure-Response Analyses for Clinical Dose-Ranging Studies of Drug Combinations

Adaptive Optimal Designs for Dose-Finding Studies with Time-to-Event Outcomes

Ryeznik, Yevgen; Sverdlov, Oleksandr; Hooker, Andrew C

Ingår i AAPS Journal, 2018

• DOI för Adaptive Optimal Designs for Dose-Finding Studies with Time-to-Event Outcomes
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A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim

Brekkan, Ari; Lopez-Lazaro, Luis; Yngman, Gunnar; Plan, Elodie L. et al.

Ingår i AAPS Journal, 2018

• DOI för A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim
• Ladda ner fulltext (pdf) av A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim

Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group

Ryeznik, Yevgen; Sverdlov, Oleksandr; Hooker, Andrew

Ingår i AAPS Journal, 2018

• DOI för Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group
• Ladda ner fulltext (pdf) av Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group

Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology

Pierrillas, Philippe B.; Fouliard, Sylvain; Chenel, Marylore; Hooker, Andrew et al.

Ingår i AAPS Journal, 2018

• DOI för Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology
• Ladda ner fulltext (pdf) av Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology

The Standard Output: A Tool-Agnostic Modeling Storage Format

Terranova, Nadia; Smith, Mike K.; Nordgren, Rikard; Comets, Emmanuelle et al.

Ingår i CPT, s. 543-546, 2018

• DOI för The Standard Output: A Tool-Agnostic Modeling Storage Format
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Reduced and optimized trial designs for drugs described by a target mediated drug disposition model

Brekkan, Ari; Jönsson, Siv; Karlsson, Mats O; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 637-647, 2018

• DOI för Reduced and optimized trial designs for drugs described by a target mediated drug disposition model
• Ladda ner fulltext (pdf) av Reduced and optimized trial designs for drugs described by a target mediated drug disposition model

Model-Informed Drug Development and Review for Generic Products: Summary Of FDA Public Workshop

Fang, Lanyan; Kim, Myong-Jin; Li, Zhichuan; Wang, Yaning et al.

Ingår i Clinical Pharmacology and Therapeutics, s. 27-30, 2018

• DOI för Model-Informed Drug Development and Review for Generic Products: Summary Of FDA Public Workshop

Model Description Language (MDL): A Standard for Modeling and Simulation

Smith, Mike K.; Moodie, Stuart L.; Bizzotto, Roberto; Blaudez, Eric et al.

Ingår i CPT, s. 647-650, 2017

• DOI för Model Description Language (MDL): A Standard for Modeling and Simulation

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)

Musuamba, F. T.; Manolis, E.; Holford, N.; Cheung, S. Y. A. et al.

Ingår i CPT, s. 418-429, 2017

• DOI för Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)

Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics

Nguyen, T. H. T.; Mouksassi, M-S; Holford, N.; Al-Huniti, N. et al.

Ingår i CPT, s. 87-109, 2017

• DOI för Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics
• Ladda ner fulltext (pdf) av Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics

Assessing robustness of designs for random effects parameters for nonlinear mixed-effects models

Duffull, Stephen B.; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 611-616, 2017

• DOI för Assessing robustness of designs for random effects parameters for nonlinear mixed-effects models

Model selection and averaging of nonlinear mixed-effect models for robust phase III dose selection

Aoki, Yasunori; Roshammar, Daniel; Hamren, Bengt; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 581-597, 2017

• DOI för Model selection and averaging of nonlinear mixed-effect models for robust phase III dose selection
• Ladda ner fulltext (pdf) av Model selection and averaging of nonlinear mixed-effect models for robust phase III dose selection

Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials

Valitalo, Pyry; Kokki, Merja; Ranta, Veli-Pekka; Olkkola, Klaus T. et al.

Ingår i Pharmaceutical research, s. 1125-1133, 2017

• DOI för Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials

The effect of using a robust optimality criterion in model based adaptive optimization.

Strömberg, Eric; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 317-324, 2017

• DOI för The effect of using a robust optimality criterion in model based adaptive optimization.
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Preconditioning of Nonlinear Mixed Effects Models for Stabilisation of Variance-Covariance Matrix Computations

Aoki, Yasunori; Nordgren, Rikard; Hooker, Andrew C.

Ingår i AAPS Journal, s. 505-518, 2016

• DOI för Preconditioning of Nonlinear Mixed Effects Models for Stabilisation of Variance-Covariance Matrix Computations

The effect of Fisher information matrix approximation methods in population optimal design calculations

Strömberg, Eric; Nyberg, Joakim; Hooker, Andrew

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 609-619, 2016

• DOI för The effect of Fisher information matrix approximation methods in population optimal design calculations
• Ladda ner fulltext (pdf) av The effect of Fisher information matrix approximation methods in population optimal design calculations

PopED lite: an optimal design software for preclinical pharmacokinetic and pharmacodynamic studies

Aoki, Yasunori; Monika, Sundqvist; Hooker, Andrew C.; Gennemark, Peter

Ingår i Computer Methods and Programs in Biomedicine, s. 126-143, 2016

• DOI för PopED lite: an optimal design software for preclinical pharmacokinetic and pharmacodynamic studies

A diagnostic tool for population models using non-compartmental analysis: The ncappc package for R

Acharya, Chayan; Hooker, Andrew C.; Turkyilmaz, Gulbeyaz Yildiz; Jönsson, Siv et al.

Ingår i Computer Methods and Programs in Biomedicine, s. 83-93, 2016

• DOI för A diagnostic tool for population models using non-compartmental analysis: The ncappc package for R
• Ladda ner fulltext (pdf) av A diagnostic tool for population models using non-compartmental analysis: The ncappc package for R

Accelerating Monte Carlo power studies through parametric power estimation

Ueckert, Sebastian; Karlsson, Mats O.; Hooker, Andrew C

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 223-234, 2016

• DOI för Accelerating Monte Carlo power studies through parametric power estimation
• Ladda ner fulltext (pdf) av Accelerating Monte Carlo power studies through parametric power estimation

Pharmacometrics Markup Language (PharmML): Opening New Perspectives for Model Exchange in Drug Development

Swat, M. J.; Moodie, S.; Wimalaratne, S. M.; Kristensen, N. R. et al.

Ingår i CPT, s. 316-319, 2015

• DOI för Pharmacometrics Markup Language (PharmML): Opening New Perspectives for Model Exchange in Drug Development
• Ladda ner fulltext (pdf) av Pharmacometrics Markup Language (PharmML): Opening New Perspectives for Model Exchange in Drug Development

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

Kågedal, Matts; Varnäs, Katarina; Hooker, Andrew C; Karlsson, Mats O

Ingår i British Journal of Clinical Pharmacology, s. 116-127, 2015

• DOI för Estimation of drug receptor occupancy when non-displaceable binding differs between brain regions: extending the simplified reference tissue model

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

Kågedal, Matts; Karlsson, Mats; Hooker, Andrew C

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 211-224, 2015

• DOI för 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

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

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

Ingår i British Journal of Clinical Pharmacology, s. 6-17, 2015

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

Simultaneous pharmacokinetic modeling of alkylresorcinols and their main metabolites indicates dual absorption mechanisms and enterohepatic elimination in humans

Marklund, Matti; Strömberg, Eric A; Lærke, Helle N; Knudsen, Knud E Bach et al.

Ingår i Journal of Nutrition, s. 1674-1680, 2014

• DOI för Simultaneous pharmacokinetic modeling of alkylresorcinols and their main metabolites indicates dual absorption mechanisms and enterohepatic elimination in humans

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.

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 639-654, 2014

• DOI för Optimal clinical trial design based on a dichotomous Markov-chain mixed-effect sleep model
• Ladda ner fulltext (pdf) av Optimal clinical trial design based on a dichotomous Markov-chain mixed-effect sleep model

Improved Utilization of ADAS-cog Assessment Data through Item Response Theory based Pharmacometric Modeling

Ueckert, Sebastian; Plan, Elodie L.; Ito, Kaori; Karlsson, Mats O. et al.

Ingår i Pharmaceutical research, s. 2152-2165, 2014

• DOI för Improved Utilization of ADAS-cog Assessment Data through Item Response Theory based Pharmacometric Modeling
• Ladda ner fulltext (pdf) av Improved Utilization of ADAS-cog Assessment Data through Item Response Theory based Pharmacometric Modeling

Evaluation of Bias, Precision, Robustness and Runtime for Estimation Methods in NONMEM 7

Johansson, Åsa M.; Ueckert, Sebastian; Plan, Elodie L.; Hooker, Andrew C. et al.

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 223-238, 2014

• DOI för Evaluation of Bias, Precision, Robustness and Runtime for Estimation Methods in NONMEM 7

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

Mentré, F; Chenel, M; Comets, E; Grevel, J et al.

Ingår i CPT, 2013

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

Modeling and Simulation Workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose

Keizer, Ron J; Karlsson, M O; Hooker, Andrew C

Ingår i CPT, 2013

• DOI för Modeling and Simulation Workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose

Optimizing disease progression study designs for drug effect discrimination

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

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 587-596, 2013

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

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

Kågedal, Matts; Cselenyi, Zsolt; Nyberg, Svante; Raboisson, Patrick et al.

Ingår i NeuroImage, s. 160-169, 2013

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

Simultaneous optimal experimental design for in vitro binding parameter estimation

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

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 573-585, 2013

• DOI för Simultaneous optimal experimental design for in vitro binding parameter estimation

Chain length of dietary alkylresorcinols affects their in vivo elimination kinetics in rats

Marklund, Matti; Strömberg, Eric A; Hooker, Andrew C; Hammarlund-Udenaes, Margareta et al.

Ingår i Journal of Nutrition, s. 1573-1578, 2013

• DOI för Chain length of dietary alkylresorcinols affects their in vivo elimination kinetics in rats

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

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

Ingår i Computer Methods and Programs in Biomedicine, s. 789-805, 2012

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

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

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

Ingår i Journal of clinical pharmacology, s. 29-38, 2012

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

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.

Ingår i Journal of clinical pharmacology, s. 347-360, 2012

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

Serial correlation in optimal design for nonlinear mixed effects models

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

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 239-249, 2012

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

Plasma and Cerebrospinal Fluid Pharmacokinetics of Naproxen in Children

Välitalo, Pyry; Kumpulainen, Elina; Manner, Minna; Kokki, Merja et al.

Ingår i Journal of clinical pharmacology, s. 1516-1526, 2012

• DOI för Plasma and Cerebrospinal Fluid Pharmacokinetics of Naproxen in Children

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

Kågedal, Matts; Cselényi, Zsolt; Nyberg, Svante; Jönsson, Siv et al.

Ingår i NeuroImage, s. 849-856, 2012

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

Joint Modeling of Efficacy, Dropout, and Tolerability in Flexible-Dose Trials: A Case Study in Depression

Russu, A.; Marostica, E.; De Nicolao, G.; Hooker, Andrew C. et al.

Ingår i Clinical Pharmacology and Therapeutics, s. 863-871, 2012

• DOI för Joint Modeling of Efficacy, Dropout, and Tolerability in Flexible-Dose Trials: A Case Study in Depression

Prediction-Corrected Visual Predictive Checks for Diagnosing Nonlinear Mixed-Effects Models

Bergstrand, Martin; Hooker, Andrew C.; Wallin, Johan E.; Karlsson, Mats O.

Ingår i AAPS Journal, s. 143-151, 2011

• DOI för Prediction-Corrected Visual Predictive Checks for Diagnosing Nonlinear Mixed-Effects Models

Optimal Design in Population Kinetic Experiments by Set-Valued Methods

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

Ingår i AAPS Journal, s. 495-507, 2011

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

Multinomial Logistic Functions in Markov Chain Models of Sleep Architecture: Internal and External Validation and Covariate Analysis

Bizzotto, Roberto; Zamuner, Stefano; Mezzalana, Enrica; De Nicolao, Giuseppe et al.

Ingår i AAPS Journal, s. 445-463, 2011

• DOI för Multinomial Logistic Functions in Markov Chain Models of Sleep Architecture: Internal and External Validation and Covariate Analysis

A Fast Method for Testing Covariates in Population PK/PD Models

Khandelwal, Akash; Harling, Kajsa; Jonsson, Niclas E.; Hooker, Andrew C. et al.

Ingår i AAPS Journal, s. 464-472, 2011

• DOI för A Fast Method for Testing Covariates in Population PK/PD Models

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.

Ingår i Drug Metabolism And Disposition, s. 858-863, 2011

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

Adaptive-Optimal Design in PET Occupancy Studies

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

Ingår i Clinical Pharmacology and Therapeutics, s. 563-571, 2010

• DOI för Adaptive-Optimal Design in PET Occupancy Studies

Plasma and cerebrospinal fluid pharmacokinetics of flurbiprofen in children

Kumpulainen, Elina; Valitalo, Pyry; Kokki, Merja; Lehtonen, Marko et al.

Ingår i British Journal of Clinical Pharmacology, s. 557-566, 2010

• DOI för Plasma and cerebrospinal fluid pharmacokinetics of flurbiprofen in children

Methodological Comparison of In Vitro Binding Parameter Estimation: Sequential vs. Simultaneous Non-linear Regression

Ernest, C. Steven; Hooker, Andrew C.; Karlsson, Mats O.

Ingår i Pharmaceutical research, s. 866-877, 2010

• DOI för Methodological Comparison of In Vitro Binding Parameter Estimation: Sequential vs. Simultaneous Non-linear Regression

Modeling subpopulations with the $MIXTURE subroutine in NONMEM: finding the individual probability of belonging to a subpopulation for the use in model analysis and improved decision making

Karlsson, Kristin C.; Savić, Radojka M.; Hooker, Andrew C.; Karlsson, Mats O

Ingår i AAPS Journal, s. 148-154, 2009

• DOI för Modeling subpopulations with the $MIXTURE subroutine in NONMEM: finding the individual probability of belonging to a subpopulation for the use in model analysis and improved decision making

Trial treatment length optimization with an emphasis on disease progression studies

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

Ingår i Journal of clinical pharmacology, s. 323-335, 2009

• DOI för 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.

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 125-145, 2009

• DOI för 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.

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 281-295, 2009

• DOI för Optimization of the intravenous glucose tolerance test in T2DM patients using optimal experimental design
• Ladda ner fulltext (pdf) av Optimization of the intravenous glucose tolerance test in T2DM patients using optimal experimental design

Population pharmacokinetic model for docetaxel in patients with varying degrees of liver function: incorporating cytochrome P4503A activity measurements

Hooker, Andrew C; Ten Tije, A J; Carducci, M A; Weber, J et al.

Ingår i Clinical Pharmacology and Therapeutics, s. 111-118, 2008

• DOI för Population pharmacokinetic model for docetaxel in patients with varying degrees of liver function: incorporating cytochrome P4503A activity measurements

Non-Bayesian Knowledge Propagation using Model Model-Based Analysis of Data from Multiple Clinical Studies

Ribbing, Jakob; Hooker, Andrew C; Jonsson, E Niclas

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 117-137, 2008

• DOI för Non-Bayesian Knowledge Propagation using Model Model-Based Analysis of Data from Multiple Clinical Studies

Pharmacokinetics of P-glycoprotein inhibition in the rat blood-brain barrier

Syvänen, Stina; Hooker, Andrew; Rahman, Obaidur; Wilking, Helena et al.

Ingår i Journal of Pharmaceutical Sciences, s. 5386-5400, 2008

• DOI för Pharmacokinetics of P-glycoprotein inhibition in the rat blood-brain barrier

Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method

Hooker, Andrew C.; Staatz, Christine E; Karlsson, Mats O

Ingår i Pharmaceutical research, s. 2187-2197, 2007

• DOI för Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method

Automated identification of axonal growth cones in time-lapse image sequences.

Keenan, Thomas M; Hooker, Andrew C.; Spilker, Mary E; Li, Nianzhen et al.

Ingår i Journal of Neuroscience Methods, s. 232-8, 2006

• DOI för Automated identification of axonal growth cones in time-lapse image sequences.

Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments.

Hooker, Andrew C.; Vicini, Paolo

Ingår i AAPS Journal, 2005

• DOI för Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments.

Robust population pharmacokinetic experiment design.

Dodds, Michael G; Hooker, Andrew C.; Vicini, Paolo

Ingår i Journal of Pharmacokinetics and Pharmacodynamics, s. 33-64, 2005

• DOI för Robust population pharmacokinetic experiment design.

POPED, a software for optimal experiment design in population kinetics.

Foracchia, Marco; Hooker, Andrew C.; Vicini, Paolo; Ruggeri, Alfredo

Ingår i Computer Methods and Programs in Biomedicine, s. 29-46, 2004

• DOI för POPED, a software for optimal experiment design in population kinetics.

An evaluation of population D-optimal designs via pharmacokinetic simulations.

Hooker, Andrew C; Foracchia, Marco; Dodds, Michael G; Vicini, Paolo

Ingår i Annals of Biomedical Engineering, s. 98-111, 2003

Quantitative magnetic resonance imaging analysis of neovasculature volume in carotid atherosclerotic plaque.

Kerwin, William; Hooker, Andrew C.; Spilker, Mary; Vicini, Paolo et al.

Ingår i Circulation, s. 851-6, 2003

Classical examination of the Stark effect in hydrogen

Hooker, Andrew C.; Greene, Chris H.; Clark, William

Ingår i Physical Review A. Atomic, Molecular, and Optical Physics, s. 4609-4612, 1997

• DOI för Classical examination of the Stark effect in hydrogen

In Silico Clinical Trials in Drug Development: A Systematic Review

Chen, Bohua; Schneider, Lucia Chantal; Röver, Christian; Comets, Emmanuelle et al.

Ingår i Therapeutic Innovation and Regulatory Science, s. 423-439, 2026

• DOI för In Silico Clinical Trials in Drug Development: A Systematic Review
• Ladda ner fulltext (pdf) av In Silico Clinical Trials in Drug Development: A Systematic Review

Methods for non-proportional hazards in clinical trials: A systematic review

Bardo, Maximilian; Huber, Cynthia; Benda, Norbert; Brugger, Jonas et al.

Ingår i Statistical Methods in Medical Research, s. 1069-1092, 2024

• DOI för Methods for non-proportional hazards in clinical trials: A systematic review
• Ladda ner fulltext (pdf) av Methods for non-proportional hazards in clinical trials: A systematic review

Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop

Gong, Yuqing; Zhang, Peijue; Yoon, Miyoung; Zhu, Hao et al.

Ingår i CPT, s. 624-630, 2023

• DOI för Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop
• Ladda ner fulltext (pdf) av Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop

Metaheuristics for pharmacometrics

Kim, Seongho; Hooker, Andrew; Shi, Yu; Kim, Grace Hyun J. et al.

Ingår i CPT, s. 1297-1309, 2021

• DOI för Metaheuristics for pharmacometrics
• Ladda ner fulltext (pdf) av Metaheuristics for pharmacometrics

Population pharmacometrics in support of analgesics studies

Valitalo, P.; Ranta, V. -P; Hooker, Andrew C.; Kokki, M. et al.

Ingår i Acta Anaesthesiologica Scandinavica, s. 143-156, 2014

• DOI för Population pharmacometrics in support of analgesics studies