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.
The GOAL of this research: 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.
To find out more information about this testing in vaccine development, please download the presentation here >
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