Module 5 Presentations

16/07/2024

OTHER TOXICOLOGIC ASSESSMENTS TO CONSIDER

• LOCAL TOLERANCE • support for non-therapeutic routes • IMMUNOTOXICOLOGY • cascade of event based on General Tox outcomes or drug class • PHOTOTOXICITY • hierarchy of physical, chemical, in vitro and in vivo tox and PK tests • photocarcinogenicity is generally not recommended • ABUSE LIABILITY • for all drugs that are “distributed to the brain and produce CNS activity” • MAJOR HUMAN METABOLITES • non-clinical safety assessment of major human metabolites • “major” is generally ≥10% of drug related material in circulation • PAEDIATRICS • DRUG SUBSTANCE and DRUG PRODUCT IMPURITIES/DEGRADANTS • DRUG COMBINATIONS

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

25

Reproductive Toxicology

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

26

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