Dosne, Anne-Gaelle Valade, Elodie Stuyckens, Kim Li, Lilian Y Ouellet, Daniele Perez-Ruixo, Juan Jose
Published in
Journal of clinical pharmacology
A population pharmacokinetic (PK) model was developed using data pooled from 6 clinical studies (3 in healthy volunteers and 3 in cancer patients) to characterize total and free plasma concentrations of erdafitinib following single- and multiple-dose administration, to understand clinically relevant covariates, and to quantify the inter- and intrai...
Shuster, Diana L Shireman, Laura M Ma, Xiaosu Shen, Danny D Flood Nichols, Shannon K Ahmed, Mahmoud S Clark, Shannon Caritis, Steve Venkataramanan, Raman Haas, David M
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Published in
Journal of clinical pharmacology
Gestational diabetes mellitus is a condition similar to type 2 diabetes mellitus (T2DM) in that patients are unable to compensate for the degree of insulin resistance, and both conditions are often treated with metformin. The comparative pharmacodynamic response to metformin in these 2 populations has not been studied. This study characterized insu...
Greger, Jessica Bates, Vernice Mechtler, Laszlo Gengo, Fran
Published in
Journal of clinical pharmacology
Legalization of medical cannabis has occurred in 33 states and the District of Columbia, and recreational use has increased exponentially since 2013. As a result, it is important to understand how cannabis interacts with other drugs and has potential risks for patients on concomitant medications. Components of medical cannabis can inhibit or compet...
Malik, Paul R V Edginton, Andrea N
Published in
Journal of clinical pharmacology
An understanding of pediatric pharmacokinetics (PK) is essential for first-in-pediatric dose selection and clinical trial design. At present, there is no reliable way to scale the PK of monoclonal antibodies and immunoglobulin G drug products from adults to young children or to premature infants-a vulnerable population with a rapidly growing drug d...
Nader, Ahmed Stodtmann, Sven Friedel, Anna Mohamed, Mohamed-Eslam F Othman, Ahmed A
Published in
Journal of clinical pharmacology
Upadacitinib (ABT-494) is a selective Janus kinase (JAK)1 inhibitor being developed for treatment of several inflammatory disorders. A population pharmacokinetic model was developed for upadacitinib using 11,658 plasma concentrations from 1145 subjects from 4 phase 1 and 5 phase 2 studies in healthy subjects and subjects with rheumatoid arthritis, ...
Liu, Michelle Obeng, Aniwaa Owusu
Published in
Journal of clinical pharmacology
Sharma, Manish R Mehrotra, Shailly Gray, Elizabeth Wu, Kehua Barry, William T Hudis, Clifford Winer, Eric P Lyss, Alan P Toppmeyer, Deborah L Moreno-Aspitia, Alvaro
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Published in
Journal of clinical pharmacology
Chemotherapy-induced peripheral neuropathy (henceforth, neuropathy) is often dose limiting and is generally managed by empirical dose modifications. We aimed to (1) identify an early time point that is predictive of future neuropathy using a patient-reported outcome and (2) propose a dose-adjustment algorithm based on simulated data to manage neuro...
Jiang, Sibo Madrasi, Kumpal Samant, Tanay Lagishetty, Chakradhar Vozmediano, Valvanera Chiew, Angela Abdel-Rahman, Susan M James, Laura P Schmidt, Stephan
Published in
Journal of clinical pharmacology
Acetaminophen protein adducts (adducts) are a well-established biomarker to diagnose acetaminophen toxicity. To date, the quantitative relationship between acetaminophen exposure, which drives adduct formation, and adduct exposure remains to be established. Our study characterized the adduct formation and disposition in adults using the approach of...
Araújo, Ana Maria Machado, Humberto de Pinho, Paula Guedes Soares-da-Silva, Patrício Falcão, Amílcar
Published in
Journal of clinical pharmacology
This study aimed to develop a population pharmacokinetic-pharmacodynamic (PKPD) model for propofol using data prospectively collected from a heterogeneous group of adult, elderly, and obese patients using the bispectral index (BIS) as a pharmacodynamic guide. Adult, obese (body mass index ≥35 kg/m2 ), and elderly patients (aged >65 years) were incl...
Velepič, Marko Manestar, Dubravko Perković, Ivona Škalamera, Dunja Braut, Tamara
Published in
Journal of clinical pharmacology
The purpose of the study was to compare treatment of chronic rhinosinusitis (CRS) with topical glucocorticoids and saline irrigation versus aerosol inhalation therapy. Patients diagnosed with CRS were randomly divided into 2 groups. In the first group, patients were treated with topical glucocorticoids (mometasone furoate, 100 µg in each nostril on...
