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Unravelling sources of variability on rocuronium pharmacokinetics: Implications for prolonged recovery in older patients.
Br J Clin Pharmacol
January 2025
Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics. College of Pharmacy, University of Florida, Orlando, FL, USA.
Aims: Residual neuromuscular blockade (RNB) commonly occurs when using neuromuscular blockers and increases the risk for pulmonary complications, such as airway obstruction and severe hypoxemia, in extubated patients. Rocuronium exhibits a high variability in recovery time, contributing to an increased risk for RNB. This study aimed to identify and characterize the sources of variability in rocuronium exposure and response via a population pharmacokinetic/pharmacodynamic (PK/PD) analysis and to apply the developed PK/PD model to investigate clinical implications.
View Article and Find Full Text PDFComprehensive Parent-Metabolite PBPK/PD Modeling Insights Into Methotrexate Personalized Dosing Strategies in Patients With Rheumatoid Arthritis.
CPT Pharmacometrics Syst Pharmacol
January 2025
Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Rheumatoid arthritis (RA) is a major public health concern, which can cause serious outcomes. Low-dose methotrexate (MTX) is a cornerstone in RA treatment, but there is significant heterogeneity in clinical response. To evaluate underlying sources of pharmacokinetic variability and clinical response of MTX, a physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) model was developed using PK-sim and Mobi (version 11.
View Article and Find Full Text PDFThe Role of Pharmacometrics in Advancing the Therapies for Autoimmune Diseases.
Pharmaceutics
December 2024
Department of Pharmacokinetics and Physical Pharmacy, Faculty of Pharmacy, Jagiellonian University Medical College, 9 Medyczna Street, 30-688 Krakow, Poland.
Autoimmune diseases (AIDs) are a group of disorders in which the immune system attacks the body's own tissues, leading to chronic inflammation and organ damage. These diseases are difficult to treat due to variability in drug PK among individuals, patient responses to treatment, and the side effects of long-term immunosuppressive therapies. In recent years, pharmacometrics has emerged as a critical tool in drug discovery and development (DDD) and precision medicine.
View Article and Find Full Text PDFDescription and Modeling of Relevant Demographic and Laboratory Variables in a Large Oncology Cohort to Generate Virtual Populations.
Pharmaceutics
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PharmaMar S.A., Clinical Pharmacology Department, Clinical Development, 28770 Madrid, Spain.
: Pathophysiological variability in patients with cancer is associated with differences in responses to pharmacotherapy. In this work, we aimed to describe the demographic characteristics and hematological, biochemical, and coagulation variables in a large oncology cohort and to develop, optimize, and provide open access to modeling equations for the estimation of variables potentially relevant in pharmacokinetic modeling. : Using data from 1793 patients with cancer, divided into training ( = 1259) and validation ( = 534) datasets, a modeling network was developed and used to simulate virtual oncology populations.
View Article and Find Full Text PDFApplication of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan.
J Pharmacokinet Pharmacodyn
January 2025
Clinical Pharmacology Development Area, MSD K.K., Tokyo, Japan.
Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness and application of MIDD in Japan, the Data Science Expert Committee of the Drug Evaluation Committee in the Japan Pharmaceutical Manufacturers Association established a task force, which surveyed MIDD applications for approved products in Japan. This study aimed to reveal the trends and challenges in the use of MIDD by analyzing the survey results.
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