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Population Pharmacokinetics of Orvacabtagene Autoleucel, an Autologous BCMA-Directed Chimeric Antigen Receptor T-Cell Product, in Patients with Relapsed/Refractory Multiple Myeloma.
Clin Cancer Res
January 2025
Bristol-Myers Squibb (United States), Summit, New Jersey, United States.
Purpose: Orvacabtagene autoleucel (orva-cel; JCARH125), a CAR T-cell therapy targeting B-cell maturation antigen (BCMA), was evaluated in relapsed/refractory multiple myeloma (RRMM) patients in the EVOLVE phase 1/2 study (NCT03430011). We applied a modified piecewise model to characterize orva-cel transgene kinetics and assessed the impact of various covariates on its pharmacokinetics (PK).
Experimental Design: The population PK analysis included 159 patients from the EVOLVE study.
Pimobendan oral solution is bioequivalent to pimobendan chewable tablets in beagle dogs.
J Vet Intern Med
January 2025
Boehringer Ingelheim Pharma GmbH & Co., Ingelheim, Germany.
Background: Myxomatous mitral valve disease (MMVD) is frequently diagnosed in small breed dogs. Pimobendan oral solution has been developed to improve dosing accuracy in small and toy breed dogs.
Hypothesis/objectives: Demonstrate bioequivalence of pimobendan oral solution with pimobendan chewable tablets using a pharmacokinetic and a pharmacodynamic study in healthy purpose bred dogs.
Pharmacokinetic characterization and exposure-response relationship of crovalimab in the COMMODORE 1, 2 and 3 and COMPOSER trials of patients with paroxysmal nocturnal haemoglobinuria.
Br J Clin Pharmacol
January 2025
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Aims: Crovalimab is a novel C5 inhibitor administered first intravenously and then subcutaneously in patients with paroxysmal nocturnal haemoglobinuria (PNH) naive to complement inhibition or switching from eculizumab or ravulizumab. Crovalimab showed efficacy and safety comparable to eculizumab in the pivotal COMMODORE 2 and supporting studies.
Methods: We characterized crovalimab pharmacokinetics and the relationship between exposure pharmacokinetic parameters and pharmacodynamic biomarkers, efficacy and safety endpoints using pooled data (healthy volunteers [n = 9], naive [n = 210] and switched [n = 211] patients).
Alopecia Management Potential of Rosemary-Based Nanoemulgel Loaded with Metformin: Approach Combining Active Essential Oil and Repurposed Drug.
Int J Nanomedicine
January 2025
Department of Pharmaceutical Sciences, School of Pharmacy, Lebanese American University, Byblos, Lebanon.
Introduction: Androgenetic alopecia (AGA) is a multifactorial and age-related dermatological disease that affects both males and females, usually at older ages. Traditional hair repair drugs exemplified by minoxidil have limitations such as skin irritation and hypertrichosis. Thus, attention has been shifted to the use of repurposing drugs.
View Article and Find Full Text PDFEvaluation of the effectiveness of GASMAN anesthesia simulation software combined with case-based learning versus traditional lecture-based learning in inhalation anesthesia education.
Front Med (Lausanne)
January 2025
Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China.
Objective: To evaluate the effectiveness of integrating GASMAN anesthesia simulation software with case-based learning (IGC) compared to traditional lecture-based learning (LBL) in teaching inhalation anesthesia to undergraduate anesthesiology students.
Methods: Fourth-year students from two academic years (2022, = 110; 2023, = 131) enrolled in a five-year anesthesiology program were assigned to either traditional lecture-based learning (LBL) or IGC groups. The LBL group received traditional lectures using PowerPoint slides, while the IGC group engaged with GASMAN anesthesia simulation software (a tool designed for anesthesia simulation and gas monitoring) combined with case-based learning.
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