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Model-based Drug Development

Clinical pharmacology and therapeutics, 2007-07, Vol.82 (1), p.21-32

2007

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Model‐Informed Development and Registration of a Once‐Daily Regimen of Extended‐Release Tofacitinib

Clinical pharmacology and therapeutics, 2017-06, Vol.101 (6), p.745-753

2017

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Modeling and Simulation to Support Dose Selection and Clinical Development of SC-75416, a Selective COX-2 Inhibitor for the Treatment of Acute and Chronic Pain

Clinical pharmacology and therapeutics, 2008-06, Vol.83 (6), p.857-866

2008

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Exposure-response modeling of average daily pain score, and dizziness and somnolence, for mirogabalin (DS-5565) in patients with diabetic peripheral neuropathic pain

Journal of clinical pharmacology, 2016-01, Vol.56 (1), p.67-77

2016

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Population Exposure‐Response Modeling of Naloxegol in Patients With Noncancer‐Related Pain and Opioid‐Induced Constipation

CPT: pharmacometrics and systems pharmacology, 2016-07, Vol.5 (7), p.359-366

2016

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Evaluating the Use of Linear Mixed‐Effect Models for Inference of the Concentration‐QTc Slope Estimate as a Surrogate for a Biological QTc Model

CPT: pharmacometrics and systems pharmacology, 2015-01, Vol.4 (1), p.1-9

2015

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Covariate selection in pharmacometric analyses: a review of methods

British journal of clinical pharmacology, 2015-01, Vol.79 (1), p.132-147

2015

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Correction: Predicting Relapsing-Remitting Dynamics in Multiple Sclerosis Using Discrete Distribution Models: A Population Approach

PloS one, 2014-01, Vol.9 (1)

2014

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THU0192 Evaluating Pharmacokinetic Predictors of Tofacitinib Clinical Response in Rheumatoid Arthritis

Annals of the rheumatic diseases, 2016-06, Vol.75 (Suppl 2), p.255-255

2016

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Modeling of Functional Assessment Questionnaire (FAQ) as continuous bounded data from the ADNI database

Journal of pharmacokinetics and pharmacodynamics, 2012-12, Vol.39 (6), p.601-618

2012

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Comparison of QTc Data Analysis Methods Recommended by the ICH E14 Guidance and Exposure-Response Analysis: Case Study of a Thorough QT Study of Asenapine

Clinical pharmacology and therapeutics, 2011-01, Vol.89 (1), p.75-80

2011

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Predicting relapsing-remitting dynamics in multiple sclerosis using discrete distribution models: a population approach

PloS one, 2013-09, Vol.8 (9), p.e73361-e73361

2013

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Evaluating Dosage Optimality for Tofacitinib, an Oral Janus Kinase Inhibitor, in Plaque Psoriasis, and the Influence of Body Weight

CPT: pharmacometrics and systems pharmacology, 2017-05, Vol.6 (5), p.322-330

2017

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Relationship between anger and pruritus perception in patients with chronic idiopathic urticaria and psoriasis

Journal of the European Academy of Dermatology and Venereology, 2008-09, Vol.22 (9), p.1062-1069

2008

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Exposure-response Analysis for Spontaneously Reported Dizziness in Pregabalin-treated Patient With Generalized Anxiety Disorder

Clinical pharmacology and therapeutics, 2008-07, Vol.84 (1), p.127-135

2008

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Population pharmacokinetics of pegaptanib sodium (Macugen(®)) in patients with diabetic macular edema

Clinical ophthalmology (Auckland, N.Z.), 2015-01, Vol.9 (default), p.323-335

2015

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Evaluation of estimation, prediction and inference for autocorrelated latent variable modeling of binary data—a simulation study

Journal of pharmacokinetics and pharmacodynamics, 2016-06, Vol.43 (3), p.275-289

Hutmacher, Matthew M.

2016

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Exposure-response modeling using latent variables for the efficacy of a JAK3 inhibitor administered to rheumatoid arthritis patients

Journal of pharmacokinetics and pharmacodynamics, 2008-04, Vol.35 (2), p.139-157

2008

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Application of a hazard-based visual predictive check to evaluate parametric hazard models

Journal of pharmacokinetics and pharmacodynamics, 2016-02, Vol.43 (1), p.57-71

2016

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Performance Characteristics for Some Typical QT Study Designs Under the ICH E-14 Guidance

Journal of clinical pharmacology, 2008-02, Vol.48 (2), p.215-224

2008

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Predicting the time to clinically worsening in mild cognitive impairment patients and its utility in clinical trial design by modeling a longitudinal clinical dementia rating sum of boxes from the ADNI database

Journal of Alzheimer's disease, 2014-01, Vol.40 (4), p.967

2014

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Integrated nonclinical and clinical risk assessment of the investigational proteasome inhibitor ixazomib on the QTc interval in cancer patients

Cancer chemotherapy and pharmacology, 2015-09, Vol.76 (3), p.507-516

2015

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AB0595 Changes in serum creatinine in patients with active rheumatoid arthritis treated with TOFACITINIB (CP-690,550)

Annals of the rheumatic diseases, 2013-06, Vol.71 (Suppl 3), p.672-672

2013

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Joint modeling of dizziness, drowsiness, and dropout associated with pregabalin and placebo treatment of generalized anxiety disorder

Journal of pharmacokinetics and pharmacodynamics, 2009-12, Vol.36 (6), p.565-584

2009

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Design evaluation for a population pharmacokinetic study using clinical trial simulations: a case study

Statistics in medicine, 2001-01, Vol.20 (1), p.75-91

2001

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Model-based Drug Development

Model‐Informed Development and Registration of a Once‐Daily Regimen of Extended‐Release Tofacitinib

Modeling and Simulation to Support Dose Selection and Clinical Development of SC-75416, a Selective COX-2 Inhibitor for the Treatment of Acute and Chronic Pain

Exposure-response modeling of average daily pain score, and dizziness and somnolence, for mirogabalin (DS-5565) in patients with diabetic peripheral neuropathic pain

Population Exposure‐Response Modeling of Naloxegol in Patients With Noncancer‐Related Pain and Opioid‐Induced Constipation

Evaluating the Use of Linear Mixed‐Effect Models for Inference of the Concentration‐QTc Slope Estimate as a Surrogate for a Biological QTc Model

Covariate selection in pharmacometric analyses: a review of methods

Correction: Predicting Relapsing-Remitting Dynamics in Multiple Sclerosis Using Discrete Distribution Models: A Population Approach

THU0192 Evaluating Pharmacokinetic Predictors of Tofacitinib Clinical Response in Rheumatoid Arthritis

Modeling of Functional Assessment Questionnaire (FAQ) as continuous bounded data from the ADNI database

Comparison of QTc Data Analysis Methods Recommended by the ICH E14 Guidance and Exposure-Response Analysis: Case Study of a Thorough QT Study of Asenapine

Predicting relapsing-remitting dynamics in multiple sclerosis using discrete distribution models: a population approach

Evaluating Dosage Optimality for Tofacitinib, an Oral Janus Kinase Inhibitor, in Plaque Psoriasis, and the Influence of Body Weight

Relationship between anger and pruritus perception in patients with chronic idiopathic urticaria and psoriasis

Exposure-response Analysis for Spontaneously Reported Dizziness in Pregabalin-treated Patient With Generalized Anxiety Disorder

Population pharmacokinetics of pegaptanib sodium (Macugen(®)) in patients with diabetic macular edema

Evaluation of estimation, prediction and inference for autocorrelated latent variable modeling of binary data—a simulation study

Exposure-response modeling using latent variables for the efficacy of a JAK3 inhibitor administered to rheumatoid arthritis patients

Application of a hazard-based visual predictive check to evaluate parametric hazard models

Performance Characteristics for Some Typical QT Study Designs Under the ICH E-14 Guidance

Predicting the time to clinically worsening in mild cognitive impairment patients and its utility in clinical trial design by modeling a longitudinal clinical dementia rating sum of boxes from the ADNI database

Integrated nonclinical and clinical risk assessment of the investigational proteasome inhibitor ixazomib on the QTc interval in cancer patients

AB0595 Changes in serum creatinine in patients with active rheumatoid arthritis treated with TOFACITINIB (CP-690,550)

Joint modeling of dizziness, drowsiness, and dropout associated with pregabalin and placebo treatment of generalized anxiety disorder

Design evaluation for a population pharmacokinetic study using clinical trial simulations: a case study

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