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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 PDF2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).
Bioanalysis
January 2025
Eli Lilly and Company, Indianapolis, IN, USA.
The 18th Workshop on Recent Issues in Bioanalysis (18th 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 18th 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 PDFAdditive Effects of Glutathione in Improving Antibiotic Efficacy in HIV- Co-Infection in the Central Nervous System: A Systematic Review.
Viruses
January 2025
College of Osteopathic Medicine of the Pacific, Western University of Health Sciences, Pomona, CA 91766, USA.
Background: HIV and tuberculosis (TB) co-infection poses a significant health challenge, particularly when involving the central nervous system (CNS), where it leads to severe morbidity and mortality. Current treatments face challenges such as drug resistance, immune reconstitution inflammatory syndrome (IRIS), and persistent inflammation. Glutathione (GSH) has the therapeutic potential to enhance treatment outcomes by improving antibiotic efficacy, reducing inflammation, and mitigating immune dysfunction.
View Article and Find Full Text PDFInvestigations of Long-Acting Formulations in Children, Adolescents, and Pregnant Women: A Systematic Review.
Pharmaceutics
January 2025
Division of Clinical Pharmacology, Department of Medicine, School of Medicine, The Johns Hopkins University, Baltimore, MD 21287, USA.
Long-acting and extended-release drug delivery strategies have greatly improved treatment for a variety of medical conditions. Special populations, specifically infants, children, young people, and pregnant and postpartum women, could greatly benefit from access to these strategies but are often excluded from clinical trials. We conducted a systematic review of all clinical studies involving the use of a long-acting intramuscular injection or implant in infants, children, young people, and pregnant and postpartum people.
View Article and Find Full Text PDFIntegrating Analytical Procedures in Routine Practices of Centralized Antiblastic Compounding Units for Valorization of Residual Compounded Drugs.
Pharmaceutics
January 2025
Department of Pharmacy, University of Salerno, 84084 Fisciano, Italy.
Background/objectives: Although extemporaneous formulations of anticancer drug products for personalized therapy are produced according to Good Hospital Pharmacy Manufacturing Practice, the lack of knowledge about drug stability under clinical conditions limits the second-time use of these highly costly medications in clinical practice. Therefore, the residual compounded drugs are considered waste and a cost item that negatively affects the healthcare system. In the context of the ever-increasing interest of the health system in applying practices in line with personalized medicine and spending review policies, this research aimed to demonstrate the feasibility of incorporating analytical techniques into daily routine practice.
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