Regulatory guidance stipulates that comparability assessment is required to support
manufacturing process changes during the development of a biological product or post-approval. …

BACKGROUND Pediatric clinical laboratories commonly measure tricarboxylic acid cycle
intermediates for screening, diagnosis, and monitoring of specific inborn errors of metabolism, …

Objective: To determine and compare physicians' and patients' thresholds for how much
reduction in risk of stroke is necessary and how much risk of excess bleeding is acceptable with …

Background In phase 2 trials, lebrikizumab, an anti-interleukin-13 monoclonal antibody,
reduced exacerbation rates and improved FEV 1 in patients with uncontrolled asthma, …

Introduction In a subset of patients with asthma, standard-of-care treatment does not achieve
disease control, highlighting the need for novel therapeutic approaches. Lebrikizumab is a …

Background. Focus groups have become an important data gathering technique in primary
care research. Objectives. This study provides an integrated review of recent articles that …

Background: Temporal trends in risk factors for cardiovascular disease and the impact of
socio-economic status on these risk factors remain unclear. Methods: Using data from the …

Background Interleukin (IL)-13 plays a key role in type 2 inflammation and is an emerging
pathogenic mediator in atopic dermatitis (AD). Objective We investigated the efficacy and …

We have completed a phase I trial in women of the proposed chemopreventive natural product
indole-3-carbinol (I3C). Women received oral doses of 400, 600, 800, 1,000, and 1,200 …

Background Asthma is a disease with marked heterogeneity in its clinical course and
response to treatment. IL-13 is central to type 2 inflammation, which contributes to many key …