Module 5 Presentations

16/07/2024

WHEN do we have to provide the information?

BEFORE FIRST DOSE TO MAN

Rodent + non-rodent Toxicology (≥14 Day ) Genetic Tox (only requires in vitro ) Safety pharmacology

Up to 6-Months (rodent) 9-Months (non-rodent) – Reflect trial duration Add in vivo genetic Tox Embryo-fetal Development; rodent, non-rodent (Pilot or Full?) Assess male reproductive targets For Phase 3: Female and Male Fertility (rat)

TRIALS IN PATIENTS

MARKETING APPROVAL

Carcinogenicity; Pre/Post natal development

Immunotoxicity, Phototoxicity, Juvenile Toxicology, Local tolerance, Impurities & Degradants, H&S, Environmental………

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

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Some of the other considerations….

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

34

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