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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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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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Matthew Hutmacher, MS (1969–2017)

CPT: pharmacometrics and systems pharmacology, 2017-08, Vol.6 (8), p.491-491

2017

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Efficient screening of covariates in population models using Wald's approximation to the likelihood ratio test

Journal of pharmacokinetics and pharmacodynamics, 2001-06, Vol.28 (3), p.253-275

2001

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How modeling and simulation have enhanced decision making in new drug development

Journal of pharmacokinetics and pharmacodynamics, 2005-04, Vol.32 (2), p.185-197

2005

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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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An algorithm for estimating the terminal half-life in pharmacokinetic studies

Computer methods and programs in biomedicine, 1994-02, Vol.42 (2), p.119-126

Kowalski, Kenneth G.

1994

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Effects of Food and Antacid on Oral Absorption of Misoprostol, A Synthetic Prostaglandin E1 Analog

Journal of clinical pharmacology, 1989-05, Vol.29 (5), p.439-443

1989

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Absorption and disposition of a new antiarrhythmic agent bidisomide in man

Pharmaceutical research, 1993-11, Vol.10 (11), p.1675-1682

1993

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A two-part mixture model for longitudinal adverse event severity data

Journal of pharmacokinetics and pharmacodynamics, 2003-10, Vol.30 (5), p.315-336

2003

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My Career as a Pharmacometrician and Commentary on the Overlap Between Statistics and Pharmacometrics in Drug Development

Statistics in biopharmaceutical research, 2015-04, Vol.7 (2), p.148-159

Kowalski, Kenneth G.

2015

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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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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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On the predictive performance of biased regression methods and multiple linear regression

Chemometrics and intelligent laboratory systems, 1990-09, Vol.9 (2), p.177-184

Kowalski, Kenneth G.

1990

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WAM (Wald's Approximation Method): a user-friendly software program for efficient covariate model building

Clinical pharmacology and therapeutics, 2004-02, Vol.75 (2), p.P42-P42

2004

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Population exposure response analysis of pregabalin in patients with generalized anxiety disorder (GAD)

Clinical pharmacology and therapeutics, 2004-02, Vol.75 (2), p.P90-P90

2004

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A semicompartmental modeling approach for pharmacodynamic data assessment

Journal of pharmacokinetics and biopharmaceutics, 1995-06, Vol.23 (3), p.307-322

1995

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Bidisomide (SC-40230), a new antiarrhythmic agent: Initial study of tolerability and pharmacokinetics

Clinical pharmacology and therapeutics, 1992-04, Vol.51 (4), p.371-378

1992

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Collapsing mechanistic models : An application to dose selection for proof of concept of a selective irreversible antagonist

Journal of pharmacokinetics and pharmacodynamics, 2005-08, Vol.32 (3-4), p.501-520

2005

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Effects of Food and Antacid on Oral Absorption of Misoprostol, A Synthetic Prostaglandin E 1 Analog

Journal of clinical pharmacology, 1989-05, Vol.29 (5), p.439-443

1989

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Bidisomide (SC-40230), a new antiarhythmic agent initial study of tolerability and pharmacokinetics

Clinical pharmacology and therapeutics, 1992, Vol.51 (4), p.371-378

1992

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The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3

Journal of acquired immune deficiency syndromes (1988), 1994-02, Vol.7 (2), p.139-147

1994

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Bronchodilator reversibility in asthma and COPD: findings from three large population studies

The European respiratory journal, 2019-09, Vol.54 (3), p.1900561

2019

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Optimizing the Rapid Evolution of Target Groundwater Potentiometric Surfaces

Transactions of the ASAE, 1986-07, Vol.29 (4), p.940-947

1986

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Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer

The New England journal of medicine, 2018-11, Vol.379 (21), p.2040-2051

2018

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Model-based Drug Development

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

Matthew Hutmacher, MS (1969–2017)

Efficient screening of covariates in population models using Wald's approximation to the likelihood ratio test

How modeling and simulation have enhanced decision making in new drug development

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

An algorithm for estimating the terminal half-life in pharmacokinetic studies

Effects of Food and Antacid on Oral Absorption of Misoprostol, A Synthetic Prostaglandin E1 Analog

Absorption and disposition of a new antiarrhythmic agent bidisomide in man

A two-part mixture model for longitudinal adverse event severity data

My Career as a Pharmacometrician and Commentary on the Overlap Between Statistics and Pharmacometrics in Drug Development

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

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

On the predictive performance of biased regression methods and multiple linear regression

WAM (Wald's Approximation Method): a user-friendly software program for efficient covariate model building

Population exposure response analysis of pregabalin in patients with generalized anxiety disorder (GAD)

A semicompartmental modeling approach for pharmacodynamic data assessment

Bidisomide (SC-40230), a new antiarrhythmic agent: Initial study of tolerability and pharmacokinetics

Collapsing mechanistic models : An application to dose selection for proof of concept of a selective irreversible antagonist

Effects of Food and Antacid on Oral Absorption of Misoprostol, A Synthetic Prostaglandin E 1 Analog

Bidisomide (SC-40230), a new antiarhythmic agent initial study of tolerability and pharmacokinetics

The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3

Bronchodilator reversibility in asthma and COPD: findings from three large population studies

Optimizing the Rapid Evolution of Target Groundwater Potentiometric Surfaces

Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer

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