Collection of toxicokinetic data has become a routine practice during the last 15 years in most general toxicity studies on pharma. It enables the correlation of pathological changes with the plasma concentration of drugs and/or their metabolites. This overview summarizes the use of the toxicokinetic data from the perspective of the toxicologic pathologist.
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Evaluation of ampicillin plus ceftobiprole combination therapy in treating Enterococcus faecalis infective endocarditis and bloodstream infection.
Sci Rep
January 2025
Infectious Diseases Clinic, Azienda Sanitaria Universitaria Friuli Centrale, 33100, Udine, Italy.
Enterococcus faecalis is responsible for numerous serious infections, and treatment options often include ampicillin combined with an aminoglycoside or dual beta-lactam therapy with ampicillin and a third-generation cephalosporin. The mechanism of dual beta-lactam therapy relies on the saturation of penicillin-binding proteins (PBPs). Ceftobiprole exhibits high affinity binding to nearly all E.
View Article and Find Full Text PDFPerilymph sampling in Mongolian gerbil, technical note and procedure evaluation.
Hear Res
January 2025
CHU Lille, Department of Otology and Neurotology, F-59000 Lille, France; Univ. Lille, France; Univ. Lille, Inserm, CHU Lille, U1008, F-59000 Lille, France.
Objective: The aim of this study is to detail and evaluate the surgical procedure for perilymph sampling from the cochlear apex in the Mongolian gerbil.
Design: Perilymph sampling from the cochlear apex was performed one to three time in 12 male gerbils aged 8 to 12 months via the submandibular route. 11 of them were previously implanted with intracochlear implants loaded with dexamethasone and placed in the scala tympani, the 12th was used to collect control samples.
Pharmacokinetic modeling of prenatal vitamin D exposure and the impact on offspring asthma and pulmonary function.
Biomed Pharmacother
January 2025
Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address:
Gestational 25-hydroxyvitamin D (25[OH]D) is important in fetal lung development and may influence offspring respiratory outcomes, making accurate exposure assessment essential to understand clinical associations. Therefore, we used the combined data from two large RCTs investigating prenatal vitamin D supplementation, which included early and late prenatal 25(OH)D measurements, to refine a population pharmacokinetic model of vitamin D-25(OH)D and estimate individual area under the curve (AUC) Z-scores. The primary outcome was physician-diagnosed offspring asthma/wheezing at ages 3 and 6 years, and lung function, as a secondary outcome, was evaluated by spirometry at the ages 6 and 8 years.
View Article and Find Full Text PDFThe prognosis for patients with acute promyelocytic leukemia (APL) has improved dramatically since the introduction of all-trans retinoic acid (ATRA) and intravenous arsenic trioxide (ATO). However, ATO administration requires daily infusions over several months, representing an onerous burden for hospitals and patients. We evaluated the bioavailability of a novel encapsulated oral ATO formulation in APL patients in first complete remission during standard-of-care consolidation.
View Article and Find Full Text PDFAssociation of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial.
Ann Rheum Dis
January 2025
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. Electronic address:
Objectives: The usefulness of methotrexate-polyglutamates (MTX-PGs) concentration for management of rheumatoid arthritis has been debated. We aimed to clarify the association of MTX-PGs concentration with efficacy and safety in MTX-naïve patients initiating MTX in a prospective interventional clinical trial.
Methods: The MIRACLE trial enrolled 300 MTX-naïve patients.
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