Module 9 2024

03/09/2024

Standard timing of nonclinical pharmacology and toxicology studies

Prior to FTIH

Prior to PH II/ III

Prior to submission

Justify antigen and adjuvant use (POC)

Material comparability studies

Select and justify species for toxicity testing

[Genotoxicity]

Repeat dose toxicity including local and systemic toxicity. Support safe clinical dose

Characterise immune response

MOA of vaccine

Developmental and reproductive toxicity (if relevant to target population (e.g. women of childbearing potential) [Studies to confirm comparability of manufacturing or formulation changes]

[ = on case to case basis]; Note - Separate non-clinical testing of adjuvant alone is also required FTIH = First Time In Human; POC = Proof of Concept; PH = Phase; MOA = Mode Of Action; Dark green = period where study typically conducted; Light green = earlier period where study may be conducted

The Organisation for Professionals in Regulatory Affairs

77

References for Vaccine Non-Clinical

Annex

The Organisation for Professionals in Regulatory Affairs

78

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