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The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.
View Article and Find Full Text PDFBayesian Borrowing With Multiple Heterogeneous Historical Studies Using Order Restricted Normalized Power Prior.
Stat Med
February 2025
U.S. Food and Drug Administration, Silver Spring, Maryland.
The recent U.S. Food and Drug Administration guidance on complex innovative trial designs acknowledges the use of Bayesian strategies to incorporate historical information based on clinical expertise and data similarity.
View Article and Find Full Text PDFThe Impact of Sleep Position Preferences on the Sleep Quality, Comfort and Catheter Care Quality in Patients After Endoscopic Nasobiliary Drainage: A Cross-Sectional Study.
J Clin Nurs
January 2025
Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Aims And Objectives: This study aimed to investigate the impact of sleep position preferences (SPP) on sleep quality, comfort and catheter care quality in patients after endoscopic nasobiliary drainage (ENBD).
Design: This was an observational prospective study.
Methods: This study included 167 participants with common bile duct stones (CBDS) who underwent ENBD from the gallstone ward of a hospital as a convenience sample.
Drug-Drug Interactions Between HIV Antivirals and Concomitant Drugs in HIV Patients: What We Know and What We Need to Know.
Pharmaceutics
December 2024
Clinical Pharmacology Unit, San Giovanni di Dio e Ruggi d'Aragona University Hospital, 84131 Salerno, Italy.
Highly active antiretroviral therapy has led to a significant increase in the life expectancy of people living with HIV. The trade-off is that HIV-infected patients often suffer from comorbidities that require additional treatment, increasing the risk of Drug-Drug Interactions (DDIs), the clinical relevance of which has often not been determined during registration trials of the drugs involved. Therefore, it is important to identify potential clinically relevant DDIs in order to establish the most appropriate therapeutic approaches.
View Article and Find Full Text PDFPartial AUCs in Long-Acting Injectables: Rationale, Challenges, Variability, Usefulness, and Clinical Relevance.
Pharmaceutics
December 2024
Pharmathen SA, 31 Spartis Str., 14452 Metamorfosi Attica, Greece.
Regulatory authorities typically require bioequivalence to be demonstrated by comparing pharmacokinetic parameters like area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C). Because in certain cases, AUC and C alone may not be adequate to identify formulation differences in early and/or late segments of the dosing interval, partial AUCs (pAUCs) have been proposed as additional metrics to evaluate bioequivalence. Even though cut-off points for pAUCs are usually decided based on clinical relevance, the identification of the correct cut-off range remains elusive in many other cases and tends to contribute to increased pAUC estimate variabilities.
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