ICPD Presents at IDSA-FDA Co-Sponsored Community-Acquired Pneumonia Clinical Trial Workshop

Albany, NY, 18 January 2008 – Institute for Clinical Pharmacodynamics (ICPD) today announced that Dr. Paul G. Ambrose presented at an Infectious Disease Society of America (IDSA) co-sponsored public workshop with the Food and Drug Administration (FDA). The aim of the two-day workshop was to help establish what standards new drugs for the treatment community-acquired pneumonia should have to meet in order to attain FDA approval. The emphasis of Dr. Ambrose’s lecture focused on how pharmacokinetic and pharmacodynamic analyses of existing clinical trial databases can provide the information needed to determine treatment effect and calculate non-inferiority margins. Dr. Ambrose also discussed how additional new clinical trial endpoints may provide a paradigm for more informative clinical trials involving agents for the treatment of community-acquired respiratory tract infections. The workshop program and the federal register notice about the workshop are available online.

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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
Info-ICPD@OrdwayResearch.org