Module 9 2021

23/03/2021

Specific Considerations for Vaccines Pre Clinical

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Nonclinical Pharmacology

Follow guidelines nonclinical evaluation of vaccines: WHO-CHMP-FDA National regulations (NR)

Goal of studies • Provide proof of principle

• Supportive of choice of antigen, adjuvant • Describe type and extent of immune response

• Inform on choice of species for toxicity studies (responds to antigen/adjuvant; well characterised immune system; model for disease (if relevant)

Choice of studies • Project dependent • In vitro and in vivo e.g.: influenza-infected ferret model, mouse immunogenicity model

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