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Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies.
AAPS J
January 2025
Pharmacometrics and Systems Pharmacology, Pfizer, Groton, Connecticut, U.S.A..
Minimizing harm is a cornerstone of ethical research practices. A drug that has undergone extensive clinical pharmacological testing in healthy participants (HPs) and a diverse selection of patients can be described with a sufficiently predictive population pharmacokinetic (PopPK) model. In impaired clearance trials, recruitment is minimized and underpowered for all but major exposure differences.
View Article and Find Full Text PDFOTUB1 mediates PARP1 deubiquitination to alleviate NAFLD by regulating HMGB1.
Exp Cell Res
January 2025
Department of Gastroenterology, The Second Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang City, 421001, Hunan province, China; Hunan Provincial Key Laboratory of Basic and Clinical Pharmacological Research of Gastrointestinal Cancer, the Second Affiliated Hospital, University of South China, Hengyang, 421001, Hunan, China; Department of Gastroenterology, Ningyuan County People's Hospital, Yongzhou City, 425600, Hunan province, China. Electronic address:
Nonalcoholic fatty liver disease (NAFLD) is a common chronic disease characterized by hepatocyte steatosis, which excludes alcohol, drugs and other definite liver damage-related factors. It has been reported that OTUB1 serves a significant role in the regulation of glucose and lipid metabolism. The present study aimed to investigate the molecular mechanism underlying the effect of OTUB1 on regulating NAFLD.
View Article and Find Full Text PDFThe pan-cancer landscape of aldo-keto reductase1B10 reveals that its expression is diminished in gastric cancer.
Front Immunol
December 2024
Hunan Province Key Laboratory of Basic and Clinical Pharmacological Research on Gastrointestinal Tumors, The Second Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, China.
Introduction: Aldo-keto reductase 1B10 (AKR1B10) is a multifunctional enzyme, which is important in cancer development and progression, but the landscape of AKR1B10 in pan-cancers and in tumor microenvironment is unclear.
Method: This study integrated the sequencing data of 33 cancer types, including gastric cancer, from TCGA project to explored the expression pattern and genetic and epigenetic alterations of AKR1B10. The association of AKR1B10 expression with clinical progression of cancers was evaluated by Kaplan-Meier analysis; the potential role of AKR1B10 in tumor microenvironment (TME) and immune-related gene expression were analyzed by PURITY, ESTIMATE, TIMER and CIBERSORT algorithms.
Augmenting clinical trials in asthma through digital technology, decentralised designs, and person-centric endpoints: opportunities and challenges.
Lancet Respir Med
December 2024
School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.
Article Synopsis
- * These technologies pave the way for decentralized clinical trials, allowing for a more inclusive study population, reduced costs, and faster access to new treatments.
- * The discussion includes the use of digital endpoints, different trial designs, a specific example of a fully decentralized asthma trial, and examines the pros and cons of these methods from various perspectives (clinicians, patients, and regulators).
Analysis of queries to a Swedish drug information centre identifies scientific knowledge gaps.
Sci Rep
December 2024
Department of Drug Treatment, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
Drug Information Centres (DICs) are providing clinicians with evidence-based support for rational drug treatment. However, knowledge gaps in the literature may hinder DICs from offering optimal guidance. This study examined the extent and nature of these knowledge gaps and their impact on clinical pharmacological advice, using real-world query data from a Swedish regional DIC.
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