Repeated measures data, such as clinical pharmacokinetic data, growth data, and dose-response data, are often inherently nonlinear with respect to a given response function and are frequently incomplete and/or unbalanced. Nonlinear random-effects models together with a variety of estimation procedures have been proposed for the analysis of such data. This paper is concerned with a straightforward procedure for estimating and comparing the parameters of a generalized mixed-effects nonlinear regression model. The asymptotic properties of the proposed estimators are given and large-sample tests of hypothesis provided. The results are applied to in vitro data on the water transport kinetics of hemodialyzers used in the treatment of patients with chronic renal failure.
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J Pharm Sci
January 2025
Clinical Pharmacology, Pharmacometrics & Bioanalysis, Bristol Myers Squibb, Princeton, NJ, USA.
Iberdomide, a novel potent cereblon E3 ligase modulator, is under investigation for multiple myeloma. This study assessed how renal impairment (RI) affects iberdomide pharmacokinetics (PK). Twenty-six subjects with varying renal function, including those with severe renal impairment and those requiring intermittent hemodialysis (IHD), received a single oral 1 mg dose of iberdomide.
View Article and Find Full Text PDFJ Frailty Aging
February 2025
National Center for Geriatrics and Gerontology, Aichi 474-8511, Japan.
Background: Skin tactile perception may indicate frailty in older adults. Although gait performance is crucial for diagnosing frailty, its association with skin tactile perception has not yet been explored.
Objectives: To examine the association between skin tactile perception and changes in step length, cadence, and gait speed in middle-aged and older adults.
Front Pharmacol
January 2025
Department of Pharmacy, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.
Objectives: To assess the pharmacokinetics and pharmacodynamics of imipenem in a retrospective cohort of hospitalized Chinese older patients.
Methods: A population pharmacokinetic (PPK) model was constructed utilizing a nonlinear mixed-effects modeling approach. The final model underwent evaluation through bootstrap resampling and visual predictive checks.
Background: Uncertainty about optimal tranexamic acid (TXA) dosage has led to significant practice variation in hip arthroplasty. We aimed to identify the optimal i.v.
View Article and Find Full Text PDFEur J Pharm Sci
January 2025
Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra, Portugal; CIBIT/ICNAS - Coimbra Institute for Biomedical Imaging and Translational Research, University of Coimbra, Portugal. Electronic address:
Zonisamide exhibits significant pharmacokinetic variability, demanding for the development of population pharmacokinetic (PopPK) models to identify key factors influencing drug disposition. This study aimed to develop and validate a PopPK to optimize zonisamide posology in patients with refractory epilepsy. A total of 114 plasma concentrations of zonisamide, obtained from 64 patients, were used for PopPK model development, employing the nonlinear mixed-effects modelling approach.
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