Characterization of the stability of analytes in biological samples collected during clinical studies together with that of critical assay reagents, including analyte stock solutions, is recognized as an important component of bioanalytical assay validation. Deficiencies in these areas often come to light during regulatory inspections. Best practices, based on current regulatory guidance, for the assessment of these issues as they pertain to ligand binding and chromatographic assays are covered in this review. Additionally, consensus recommendations reached during the recent AAPS/FDA Workshop on bioanalytical assay validation are highlighted.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751400 | PMC |
| http://dx.doi.org/10.1208/aapsj0902013 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Key Strategies to Promote Professional Wellness and Reduce Burnout in Oncology Clinicians.
JCO Oncol Pract
January 2025
The US Oncology Network, The Woodlands, TX.
Burnout in oncologists has been increasing, especially after the COVID-19 pandemic. This is concerning because burnout can have both personal and professional repercussions, as well as a negative impact on patients and organizational financial health. Drawing on information and ideas discussed at an ASCO Town Hall session at the 2023 Annual Meeting developed by the State of Cancer Care in America Editorial Board, this study reviews key organizational strategies for improving professional well-being and argues for the importance of measuring and researching the well-being of the oncology workforce to ensure healthy work environments.
View Article and Find Full Text PDFStatistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial.
Crit Care Sci
January 2025
Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.
Background: ANDROMEDA-SHOCK 2 is an international, multicenter, randomized controlled trial comparing hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock to standard care resuscitation to test the hypothesis that the former is associated with lower morbidity and mortality in terms of hierarchal analysis of outcomes.
Objective: To report the statistical plan for the ANDROMEDA--SHOCK 2 randomized clinical trial.
Methods: We briefly describe the trial design, patients, methods of randomization, interventions, outcomes, and sample size.
Quality assessment of clinical guidelines in the care of laryngitis and pharyngitis according to AGREE II.
Codas
January 2025
Departamento de Farmácia, Universidade de Brasília - UnB - Brasília (DF), Brasil.
Purpose: The study aimed to identify and assess the methodological quality of essential clinical guidelines for the management of laryngitis and pharyngitis.
Methods: A systematic search of clinical guidelines for the management of laryngitis and pharyngitis was performed in three databases. Methodological quality was assessed according to AGREE II, in which each item in its domains was scored by four independent evaluators.
Assessment of level of knowledge and satisfaction of website about cleft lip and palate.
Codas
January 2025
Universidade Vale do Rio Doce - UNIVALE - Governador Valadares (MG), Brasil.
Purpose: To promote orientation about cleft lip and palate and to verify knowledge and satisfaction of an orientation program through a website developed for students and health professionals.
Methods: This is a cross-sectional study, 13 healthcare professionals and 81 students from the areas of nursing, speech-language pathologist, medicine, nutrition, dentistry, and psychology participated. The research consisted of three stages: filling out a pre-program questionnaire, accessing the website (http://fissuralabiopalatina.
Improved Risk Adjustment for Comorbid Diagnoses in Administrative Claims Analyses of Orthopaedic Surgery.
J Bone Joint Surg Am
January 2025
Department of Orthopaedic Surgery, Stanford University, Redwood City, California.
Background: The accurate inclusion of patient comorbidities ensures appropriate risk adjustment in clinical or health services research and payment models. Orthopaedic studies often use only the comorbidities included at the index inpatient admission when quantifying patient risk. The goal of this study was to assess improvements in capture rates and in model fit and discriminatory power when using additional data and best practices for comorbidity capture.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!