Module 5 Presentations

16/07/2024

Biopharmaceuticals – big molecules, small differences?

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

41

Two Primary Differences between Biopharmaceuticals and NCE’s

Types of Toxicity………. • Exaggerated pharmacodynamic responses • 2 µg/kg dose of insulin produces significant hypoglycaemia in dogs • Biological toxicity • Vascular leak syndrome and hepatocyte necrosis as result of IL-2 stimulated lymphocytes • Intrinsic toxicity (ie. reproducible in animals and occurs dose-dependently at sublethal doses) • More typical for SME. Fewer published examples for biopharmaceuticals Therefore it is imperative to evaluate toxicity in pharmacologically relevant species

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

42

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