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Population pharmacokinetics and exposure-response analysis of durvalumab in combination with gemcitabine and cisplatin in patients with advanced biliary tract cancer.
Cancer Chemother Pharmacol
January 2025
Clinical Pharmacology & Quantitative Pharmacology, BioPharmaceuticals R&D, AstraZeneca, Waltham, MA, USA.
Purpose: Durvalumab in combination with gemcitabine/cisplatin has shown a favorable benefit-risk profile in the TOPAZ-1 study for advanced biliary tract cancers (BTC). This analysis evaluated the population pharmacokinetics (PopPK) of durvalumab, and exposure-response for efficacy and safety (ERES) of TOPAZ-1.
Methods: The PopPK model for durvalumab was updated using data from 5 previously analysed studies and TOPAZ-1.
Viability Assessment During Normothermic Machine Liver Perfusion: A Literature Review.
Liver Int
February 2025
Department of Hepatobiliary and Digestive Surgery, University Hospital, Rennes 1 University, Rennes, France.
The discrepancy between donor organ availability and demand leads to a significant waiting-list dropout rate and mortality. Although quantitative tools such as the Donor Risk Index (DRI) help assess organ suitability, many potentially viable organs are still discarded due to the lack of universally accepted markers to predict post-transplant outcomes. Normothermic machine perfusion (NMP) offers a platform to assess viability before transplantation.
View Article and Find Full Text PDFAnnual cholangitis more than twice predicts liver transplant in biliary atresia patients who achieve jaundice-free after Kasai portoenterostomy.
J Formos Med Assoc
January 2025
Division of Gastroenterology, Department of Pediatrics, Linkou Chang Gung Memorial Hospital, Taoyuan City 33305, Taiwan; Liver Research Center, Linkou Chang Gung Memorial Hospital, No.5, Fuxing St., Guishan Dist., Taoyuan City, 33305, Taiwan; Chang Gung University College of Medicine, No. 259, Wenhua 1st Rd., Guishan Dist., Taoyuan City, 33302, Taiwan. Electronic address:
Background: Biliary atresia (BA) is a progressive liver disease even after Kasai portoenterostomy (KPE), and the most common cause of liver transplant (LT) in the pediatric population. This study aimed to unveil the risk factors for LT in BA patients post-KPE.
Methods: We conducted a retrospective study of BA patients in a northern Taiwan Children's Medical Center from Jan 2000 to Oct 2020.
Post-ERCP clearance of bile duct stones: should the gallbladder be left in-situ?
Surg Endosc
January 2025
Department of General Surgery, Northampton General Hospital NHS Trust, Cliftonville, Northamptonshire, NN15BD, UK.
Background: Endoscopic retrograde cholangiopancreatography (ERCP) has become the gold standard management for patients who present with common bile duct stone (CBDS). Although laparoscopic cholecystectomy is generally recommended for patients who have CBDS clearance, there is still a significant proportion of patients who are managed expectantly. Our study aimed to evaluate the outcomes of expectant management (EM) versus prophylactic cholecystectomy after initial endoscopic removal of CBDS.
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.
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