Module 5 Presentations

16/07/2024

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

39

Biopharmaceuticals - What’s the difference?

Aspirin

ICH S6

 Enzymes  Cytokines

 Plasma-derived  Oigonucleotides  Growth factors  Hormones  and others….. but not….  Gene Therapy  DNA vaccines  Vaccines

Monoclonal Antibody (~100 approved )

Erythropoietin

~300 “biopharmaceuticals”

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

40

20