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Presentation: Set up of phase I unit for viral challenge testing in vaccine development

Set up of phase I unit for viral challenge testing in vaccine development
·         Discussing regulatory requirements for obtaining permission for viral inoculation studies?
·         Adjusting a phase I unit to perform safely viral challenge testing
·         Using influenza and other viral challenging in prevention and treatment studies
Dr Robert Lins, Senior Clinical Adviser - Clinical Research, SGS Belgium NV

This presentation from Dr Robert Lins discusses the goal, background, methods and results concerning the viral challenge testing in phase 1.

GOAL: to perform virus challenge studies in a Clinical Pharmacology Unit, as proof of concept (POC) trials, after initial activity assessments and phase I human pharmacokinetic (PK) and tolerability studies, and in order to better define the dose ranges to be used in phase II dose ranging trials
 
 

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