Publications by authors named "Sheila Jacobs"
Aims: To assess the single-dose pharmacokinetics and tolerability of pegylated interferon-alpha2b (PEG-Intron) in young and elderly healthy subjects.
Methods: In this parallel-design study, a single 1 microg x kg(-1) PEG-Intron dose was given subcutaneously to 24 subjects in the age groups 20-45, 65-69, 70-74 and 75-80 years (n = 6/group). Blood sampling and tolerability assessments were performed up to 168 h postdose.
A biosensor-based assay, using a surface plasmon resonance detection system, was developed to detect and isotype anti-adenoviral antibodies in patients dosed with an adenoviral-based gene therapy vector. In the assay, whole, intact virus was immobilized onto the sensor chip surface. Electron microscopy and monoclonal antibody studies provide evidence that the virus remains intact after immobilization.
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- The study investigates the pharmacokinetics and safety of pegylated interferon-alpha2b (PEG-Intron) in individuals with varying levels of kidney function, including those on hemodialysis.
- It categorizes participants into five groups based on renal function, administering a single subcutaneous dose of PEG-Intron and assessing effects over 168 hours.
- Findings indicate that while PEG-Intron is generally safe and well-tolerated, its clearance is significantly affected by renal function, with hemodialysis not impacting its apparent clearance.