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A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments.
Clin Pharmacol Ther
January 2025
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Comparisons of maximum drug concentration (C) and total area under the concentration vs. time curve (AUC) may be inadequate for bioavailability (BA)/bioequivalence (BE) assessments in cases where the shape of the pharmacokinetic (PK) profile of a drug impacts the clinical performance. In such cases, partial area under the concentration vs.
View Article and Find Full Text PDFRole of the International Society of Liquid Biopsy (ISLB) in establishing quality control frameworks for clinical integration.
Crit Rev Oncol Hematol
January 2025
Division of Medical Oncology, The Arthur G. James Comprehensive Cancer Center, Columbus, OH, USA.
Liquid biopsy (LB) has revolutionized molecular pathology, offering non-invasive insights into tumor biology. However, widespread adoption is hindered by a lack of standardized protocols, requiring robust quality control and harmonized workflows. Large-scale studies are needed to establish effective standard operating procedures (SOPs), particularly for circulating tumor DNA (ctDNA) assays tailored to different disease stages.
View Article and Find Full Text PDFRegulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - A stakeholder meeting report.
Biologicals
January 2025
Centre for Human Drug Research (CHDR), Leiden, the Netherlands; Leiden University Medical Center (LUMC), Leiden, the Netherlands.
Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs.
View Article and Find Full Text PDFRecurrent glioblastoma in national guidelines on the diagnosis and treatment of gliomas: A matter of European practice variation.
Brain Spine
October 2024
Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.
Introduction: The optimal treatment for recurrent glioblastoma patients remains not well-defined in international guidelines. On top of that, the availability of national guidelines is uncharted.
Research Question: This study aimed to investigate the availability of national guidelines on the diagnosis and treatment of adult glioma throughout Europe, specifically focusing on recurrent glioblastoma.
Developing, implementing, and evaluating the first national Memory and Cognition Clinic Guidelines in Australia.
Alzheimers Dement (N Y)
January 2025
Centre for Healthy Brain Ageing (CHeBA), Discipline of Psychiatry and Mental Health, School of Clinical Medicine University of New South Wales Kensington New South Wales Australia.
Introduction: A lack of national consensus on the roles and responsibilities of Australian memory and cognition clinics contributes to the large variability seen across services. The introduction of guidelines and a quality assessment framework could facilitate greater harmonization and quality improvements.
Methods: We used a modified Delphi process to develop the guidelines.
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