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Pharmacodynamic Models in Phase I
Clinical Trials:
A Dynamic Approach
The primary focus in Phase I clinical trials has traditionally been the assessment of safety, tolerability and pharmacokinetics. However, the past decade has seen increasing interest in the application of biomarkers and surrogate endpoints in healthy volunteer studies, to provide information on the putative efficacy, dose response and time effects of investigational drugs.
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UK well positioned
for Exploratory Clinical Development
The decision to outsource elements of early development to a CRO and the subsequent choice of regulatory jurisdiction is one of the key challenges facing clinical development teams as we move towards the end of
the first decade of the 21st century.
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Newsbriefs
ICON recently announced the acquisition of Healthcare Discoveries, an 85-bed clinical pharmacology unit in San Antonio, Texas,
with significant experience in early phase development.
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The Immunogenicity
of Biopharmaceuticals:
From horse serum to fusion proteins… and beyond
A century ago, the use of therapeutic horse serum for children with diphtheria or streptococcal infections was a last chance life-saving measure. Dr. Clemens von Pirquet noted that initial administration of the serum often made children sick while a second exposure resulted in a much accelerated reaction.
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ICON Profile
George J. Atiee M.D., Associate Medical Director ICON Development Solutions
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Did you know?
Fast Facts.
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