Module 9 2024

03/09/2024

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, protein expression

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Follow guidelines on the conduct of toxicity studies ICH- CHMP- FDA National regulations (NR) and on the nonclinical evaluation of vaccines: WHO-CHMP-FDA National regulations (NR)

Nonclinical Toxicology

Goal of studies – before administering to humans…

• Help define safe dose of antigen/adjuvant • Identify unknown or potential adverse effects

Choice of studies

• Depends on target population (e.g. women of childbearing potential? *) • Systemic toxicity/local tolerance assessment required prior to FTIH

Not applicable or only case to case: -safety pharmacology -Genotoxicity -Carcinogenicity

*Developmental and Reproductive toxicity

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