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Use of a mouse-human chimeric anti-α-galactosidase A monoclonal antibody as a reference for measuring serum antidrug antibody titers in patients with Fabry disease.
Mol Genet Metab
January 2025
Department of Clinical Genetics, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo 204-8588, Japan. Electronic address:
The detection of antidrug antibodies (ADAs) is important for monitoring patients with Fabry disease who are undergoing enzyme replacement therapy (ERT) with recombinant α-galactosidase A (GLA) drugs, as ADAs can cause allergic reactions and reduce therapeutic efficacy. Various immunological methods, particularly enzyme-linked immunosorbent assay (ELISA), are widely used to measure serum ADA titers in patients with Fabry disease. However, estimating and comparing results of ELISA is challenging because of the absence of a reference antibody.
View Article and Find Full Text PDFThe use of population pharmacokinetics to extrapolate food effects from human adults and beagle dogs to the pediatric population illustrated with ibuprofen as a case.
Int J Pharm
January 2025
Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, Ghent 9000, Belgium; Clinical Pharmacology and Pharmacometrics, Janssen R&D, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.
Oral drug administration is the most convenient route of administration in the pediatric population. However, children are often not fasted when drugs are orally administered, hence potential food-drug interactions might occur. Most of these interactions are extrapolated from studies performed in human adults where a recommended high-fat, high-calorie meal is administered prior to drug dosing.
View Article and Find Full Text PDFA matrix tool to foster patient engagement in children, adolescents and young adults: report from a multistakeholder workshop.
Res Involv Engagem
November 2024
Department of Internal Medicine and Pediatrics (GE35), Ghent University, Ghent, Belgium.
Background: Patient engagement has become increasingly important in drug development, yet structured guidance to engage children (2-11 years old), adolescents (12-17 years old), and young adults (18-24 years old) is lacking. This study aims to create a matrix tool to foster paediatric patient engagement in drug development by hosting a multistakeholder workshop.
Methods: A matrix tool was co-developed by the study team and the expert group to provide a framework for paediatric patient engagement across drug development stages.
Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab.
AAPS J
November 2024
Clinical Bioanalysis Group, Samsung Bioepis Co., Ltd, 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea.
Immunogenicity assessment is vital in clinical trials and is measured through a multi-tiered approach (screening, confirmatory and titer assays). However, recent studies have suggested that titer results could be reported from ADA signal-to-noise ratios (S/N ratios=sample mean signal/negative control mean signal). More data analysis using two clinical trials of adalimumab: SB5-1003 (single-dose, healthy participants) and SB5-4001 (multiple-dose, interchangeability study, patients with plaque psoriasis), therefore, is indispensable whether substituting ADA S/N ratio as an alternative way of reporting titer results has no impact on interpretation on clinical outcome.
View Article and Find Full Text PDFDeep Learning-Assisted Label-Free Parallel Cell Sorting with Digital Microfluidics.
Adv Sci (Weinh)
January 2025
Beijing Advanced Innovation Center for Intelligent Robots and Systems, School of Mechatronical Engineering, Beijing Institute of Technology, Beijing, 100081, China.
Article Synopsis
- A novel label-free cell sorting method combines deep learning and microfluidic technology to differentiate cells based on their shape, achieving high precision and purity in sorting.
- Using an Active-Matrix Digital Microfluidics platform, the method employs the YOLOv8 model for accurate droplet classification and incorporates advanced algorithms for efficient path planning.
- Experimental results demonstrated impressive sorting capabilities with HeLa cells, achieving up to 98.5% precision and effective recovery rates, highlighting its potential for clinical and research applications in cell biology.
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