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A simple LC-MS/MS assay for the quantification of E6011, a novel anti-fractalkine monoclonal antibody, in cynomolgus monkey serum - comparison with ligand binding assay.
J Pharm Biomed Anal
December 2024
Global Drug Metabolism and Pharmacokinetics, Eisai Co., Ltd., Tokodai 5-1-3, Tsukuba-shi, Ibaraki 300-2635, Japan; Laboratory of Genomics-based Drug Discovery, Faculty of Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan. Electronic address:
E6011 is a monoclonal antibody that is currently under development for the treatment of rheumatoid arthritis. While ligand binding assays (LBAs) are typically employed for the determination of therapeutic antibodies, ultra-performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS) represents an alternative platform. E6011 in monkey serum was treated with ammonium sulfate to obtain pellets for subsequent processing.
View Article and Find Full Text PDFBackground: Alzheimer's disease (AD) affects millions of Americans, with potential future increases without breakthroughs in treatment. IGC-AD1, a novel formulation comprising of delta-9 tetrahydrocannabinol ("THC") and melatonin, is being studied in AD-associated agitation. THC is predominantly metabolized by cytochrome P450 and specifically by CYP2C9.
View Article and Find Full Text PDFSustained-Release Solid Dispersions of Fenofibrate for Simultaneous Enhancement of the Extent and Duration of Drug Exposure.
Pharmaceutics
December 2024
College of Pharmacy, Dongguk University-Seoul, Dongguk-ro-32, Ilsan-Donggu, Goyang 10326, Republic of Korea.
Background/objectives: A sustained-release formulation of fenofibrate while enhancing drug dissolution with minimal food effect is critical for maximizing the therapeutic benefits of fenofibrate. Therefore, this study aimed to develop an effective solid dispersion formulation of fenofibrate for simultaneous enhancement in the extent and duration of drug exposure.
Methods: Fenofibrate-loaded solid dispersions (FNSDs) were prepared using poloxamer 407 and Eudragit RSPO at varied ratios via solvent evaporation.
Personalized Secukinumab Treatment in Patients with Plaque Psoriasis Using Model-Informed Precision Dosing.
Pharmaceutics
December 2024
Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia, 46100 Valencia, Spain.
Patient care and control of inflammatory disorders, such as psoriasis, can be improved by model-informed precision dosing (MIPD) techniques based on population pharmacokinetic/pharmacodynamic (PK/PD) models. Clinical dose selection decisions based on MIPD strategies need to take account of the uncertainty associated with the individual PK/PD model parameters, which is determined by the quantity of individual observational data collected in clinical practice. The aim of this study was to propose an approach for personalized dosage regimens of secukinumab (SCK) in 22 Spanish patients with plaque psoriasis, whose severity level was considered moderate to severe, taking into account the uncertainty associated with individual parameters in a population-based PK/PD model.
View Article and Find Full Text PDFIntegration of Ontogeny-Based Changes for Predicting the Exposure of Diphenhydramine in the Pediatric Population: A PBPK Modeling Approach.
Pharmaceutics
December 2024
Institute for Advanced Biosciences (IAB), CNRS UMR5309, INSERM U1209, Grenoble Alpes University, 38700 La Tronche, France.
Background: Diphenhydramine is an anti-tussive used periodically to treat seasonal colds, contact dermatitis, and anaphylactic reactions. This study aimed to develop a physiologically based pharmacokinetic (PBPK) model of diphenhydramine in predicting its systemic exposure among healthy pediatrics (children and adolescents) by leveraging data files from adults (young and elderly).
Methods: The data profiles comprising serum/plasma concentration over time and parameters related to diphenhydramine were scrutinized via exhaustive literature analysis and consolidated in the PK-Sim software version 11.
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