Method for the Study of Sinusitis Developed by ICPD Scientists Cited in FDA Industry Guidance

Albany, NY, 30 October 2007 – The Institute for Clinical Pharmacodynamics (ICPD) today announced that a novel method, pioneered in collaboration with Drs. Jack B. Anon, Paul G. Ambrose, and Ronald N. Jones, was cited in the revised Food and Drug Administration (FDA) guidance for Industry. The guidance, entitled, “Acute Bacterial Sinusitis: Developing Drugs for Treatment”, refers to the placement of a small-bore catheter into the maxillary sinus. Such a catheter allows for serial sampling of sinus aspirate for microbiologic and pharmacokinetic information. According to Dr. Ambrose, Director of ICPD, “data derived using this study design has allowed, for the first time, the characterization of drug exposure in this closed space of infection and drug effect”. To date, this technique has been used to evaluate the time-course of drug concentration, bacterial eradication and inflammatory markers. “The use of a serial sampling methodology allows for the opportunity to optimize dose and identify the optimal length of therapy for acute maxillary sinusitis”, added Dr. Ambrose.

About ICPD, Ordway Research Institute

The ICPD serves as a center for translational science collaboration to the world. We help pharmaceutical and biotechnology companies develop more effective and safer drugs through advanced methods of pharmacokinetic and pharmacodynamic system analysis. Our general contact information is as follows:

Telephone: (518) 429-2600
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