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Approximations of the target-mediated drug disposition model and identifiability of model parameters
TLDR
This paper introduces quasi-steady-state (QSS) and Michaelis-Menten (MM) approximations of the TMDD model and proposes an algorithm for establishing identifiability of these models, and tests this algorithm on simulated datasets. Expand
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Applying Bailer's Method for AUC Confidence Intervals to Sparse Sampling
Bailer (1) developed a method for constructing confidence intervals for areas under the concentration-vs-time curve (AUC's) with only one sample per subject but with multiple subjects sampled at eachExpand
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Double blind, placebo controlled trial of the remission inducing and steroid sparing properties of an ICAM-1 antisense oligodeoxynucleotide, alicaforsen (ISIS 2302), in active steroid dependent
Background and aims: To evaluate the safety and efficacy of the intercellular adhesion molecule 1 (ICAM-1) antisense phosphorothioate oligonucleotide alicaforsen (ISIS 2302) in Crohn's disease.Expand
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Population Pharmacokinetics of Eltrombopag in Healthy Subjects and Patients With Chronic Idiopathic Thrombocytopenic Purpura
The population pharmacokinetics of eltrombopag were characterized in healthy subjects (n = 111) and patients with idiopathic thrombocytopenic purpura (ITP) (n = 88) using nonlinear mixed‐effectsExpand
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Population pharmacokinetics of dabrafenib, a BRAF inhibitor: Effect of dose, time, covariates, and relationship with its metabolites
Dabrafenib is a BRAF kinase inhibitor indicated for the treatment of BRAF V600E mutation‐positive melanoma. The population pharmacokinetics of dabrafenib, including changes over time and relevantExpand
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The variance of a better AUC estimator for sparse, destructive sampling in toxicokinetics.
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Target-mediated drug disposition model: approximations, identifiability of model parameters and applications to the population pharmacokinetic–pharmacodynamic modeling of biologics
Models for drugs exhibiting target-mediated drug disposition (TMDD) describe biological processes in which drug-target binding significantly influences both pharmacodynamics (PD) and pharmacokineticsExpand
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Population Pharmacokinetics of Obinutuzumab (GA101) in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma and Exposure–Response in CLL
Treatment regimens involving obinutuzumab (GA101) demonstrated increased efficacy to rituximab in clinical trials for non‐Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). However, theExpand
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Comparison of Nonmem 7.2 estimation methods and parallel processing efficiency on a target-mediated drug disposition model
TLDR
The paper compares performance of Nonmem estimation methods—first order conditional estimation with interaction (FOCEI), iterative two stage (ITS), Monte Carlo importance sampling (IMP), importance sampling assisted by mode a posteriori (IMPMAP), stochastic approximation expectation–maximization (SAEM), and Markov chain Monte Carlo Bayesian (BAYES), on the simulated examples of a monoclonal antibody with target-mediated drug disposition (TMDD). Expand
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Population pharmacodynamics in patients receiving tinzaparin for the prevention and treatment of deep vein thrombosis.
OBJECTIVES We conducted population anticoagulant pharmacodynamic analysis for patients administered the low-molecular weight heparin tinzaparin. METHODS Data from 425 patients (2,631 observations)Expand
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